Department of Health and Human Services
DEPARTMENTAL APPEALS BOARD
Civil Remedies Division
Center for Tobacco Products,
Complainant,
v.
Infinity Petroleum, Inc.
d/b/a Shell / Snack Shop,
Respondent.
Docket No. T-24-3927
FDA Docket No. FDA-2024-H-3638
Decision No. TB10760
INITIAL DECISION
The Center for Tobacco Products (CTP) seeks a $687 civil money penalty against Respondent, Infinity Petroleum, Inc. d/b/a Shell / Snack Shop, located at 13811 Annapolis Road, Bowie, Maryland 20720. Specifically, CTP alleges that Respondent sold covered tobacco products to underage purchasers and failed to verify that the purchasers were 21 years of age or older, thereby violating the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 301 et seq. and its implementing regulations at least three times within a 24-month period.1 For the reasons discussed below, I find that Respondent committed the violations as alleged and conclude that the requested penalty of $687 is appropriate.
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I. Background and Procedural History
CTP initiated this matter by serving an administrative complaint on Respondent at 13811 Annapolis Road, Bowie, Maryland 20720, by United Parcel Service, and by filing a copy of the complaint with the FDA’s Division of Dockets Management. Civil Remedies Division (CRD) Docket (Dkt.) Entry Numbers (Nos.) 1, 1b. On August 26, 2024, Respondent, timely filed an answer to the complaint. CRD Dkt. Entry No. 3. In its answer, Respondent denied the allegations and disputed the amount of the CMP. Id.
On September 26, 2024, I issued an Acknowledgment and Pre-Hearing Order (APHO). CRD Dkt. Entry No. 4. The APHO outlined the procedures governing the case and established deadlines for completing discovery and for the parties to file pre-hearing exchanges. Id.
On October 27, 2024, Respondent filed its pre-hearing brief, well before the January 6, 2025 deadline set forth in the APHO. CRD Dkt. Entry Nos. 5, 6.2 On October 28, 2024, CTP filed a joint status report stating that the parties were unable to reach a settlement agreement. CRD Dkt. Entry No. 8. The joint status report further indicated that CTP remained willing to discuss settlement but otherwise intended to proceed to a hearing. Id.
On December 3, 2024, CTP filed a Motion to Compel Discovery, stating that it served document requests on Respondent on October 28, 2024, but Respondent failed to respond. CRD Dkt. Entry No. 9. CTP also separately filed an Unopposed Motion to Extend Deadlines, requesting that I extend the deadlines for the parties’ pre-hearing exchanges by 30 days to allow time to resolve the discovery issue. CRD Dkt. Entry No. 10.
On December 6, 2024, I issued an Order granting CTP’s Motion to Extend Deadlines and extended the pre-hearing exchange deadlines by an additional 30 days. CRD Dkt. Entry No. 11. I also advised Respondent that it had until December 23, 2024, to file a response to CTP’s Motion to Compel Discovery and warned Respondent that if it failed to file a response, “I may grant CTP’s motion in its entirety.” Id. at 1.
On January 10, 2025, after Respondent failed to respond to CTP’s Motion to Compel Discovery, I granted the motion and ordered Respondent to produce all documents responsive to CTP’s document requests by January 23, 2025. CRD Dkt. Entry No. 12. I also extended the pre-hearing exchange deadlines again to account for the discovery delay. Id. at 2. On January 24, 2025, CTP filed a Motion to Impose Sanctions stating that Respondent had not complied with my Order granting its Motion to Compel. CRD Dkt. Entry No. 13. CTP also filed a motion to stay all pre-hearing deadlines pending resolution of the Motion to Impose Sanctions. CRD Dkt. Entry No. 14.
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On January 28, 2025, I granted CTP’s request to stay all pre-hearing deadlines pending resolution of its Motion to Impose Sanctions. CRD Dkt. Entry No. 15. I also advised Respondent that it had until February 11, 2025 to file a response to CTP’s Motion to Impose Sanctions. Id. at 2.
On January 29, 2025, Respondent filed six documents, including a copy of its 2023 business tax return and photographs of signage in its establishment, that appear to be responses to CTP’s document requests. See CRD Dkt. Entry Nos. 16, 17, 17a-17d. The filings were not accompanied by any written response to the Motion to Impose Sanctions. On February 13, 2025, I issued an order directing CTP to file a status report by February 27, 2025, stating whether the filings satisfied Respondent’s outstanding discovery obligations and resolved the Motion to Impose Sanctions. CRD Dkt. Entry No. 18.
On February 24, 2025, CTP filed a status report stating that Respondent had satisfied its outstanding discovery obligations and, as a result, CTP was withdrawing the Motion to Impose Sanctions. CRD Dkt. Entry No. 20. Therefore, on March 3, 2025, I issued an order denying Respondent’s Motion to Impose Sanctions as moot. CRD Dkt. Entry No. 21. I also lifted the previously issued stay of the pre-hearing deadlines and established new deadlines for the parties to file their pre-hearing exchanges. Id. at 2.
On April 28, 2025, CTP submitted its pre-hearing brief (CTP Br.) and 20 proposed exhibits (CTP Exs. 1-20), including the written direct testimony of two witnesses, James Bowling, Deputy Division Director, Division of Enforcement and Manufacturing, Office of Compliance and Enforcement, CTP, FDA (CTP Ex. 3) and Francis D. Forney, FDA‑commissioned officer with the state of Maryland (CTP Ex. 4). CRD Dkt. Entry Nos. 22, 22a-22u. Respondent did not supplement its previously filed pre-hearing brief with any proposed exhibits or testimony other than the above-mentioned discovery responses that were filed on January 29, 2025. CRD Dkt. Entry Nos. 16, 17, 17a-17d
On July 24, 2024, I held a pre-hearing conference (PHC) with the parties to discuss their pre-hearing submissions and determine whether an oral hearing would be necessary. See CRD Dkt. Entry No. 27 (Order Following PHC). During the PHC, I went over the parties’ evidentiary submissions. Id. at 2. I explained that CTP had filed 20 proposed exhibits and asked Respondent if it had any objections to admitting the exhibits into the record. Id. Respondent stated he had no specific objections but had difficulty understanding some of the documents. Id. Based on Respondent’s statements and unrepresented status, I stated that I would give Respondent 10 additional days from the date of the PHC to further review CTP’s proposed exhibits and file any written objections. Id.
During the PHC, I also noted that Respondent filed a pre-hearing brief without any proposed exhibits, but that it had previously filed six documents in response to CTP’s
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Motion to Impose Sanctions, including copies of its 2023 business tax return and photographs of its premises. Id.; see also CRD Dkt. Entry Nos. 16, 17, 17a-17d. Because the documents were filed prior to the pre-hearing exchange deadline and were potentially relevant to Respondent’s defenses, I asked CTP whether it had any objections to admitting the documents into the record as evidence. CRD Dkt. Entry No. 27 at 2. CTP stated it had no objections. Id. Accordingly, I admitted Respondent’s January 29, 2025 documents into the administrative record and subsequently marked the submissions as Respondent’s Exhibits (R. Exs.) 1-6 in the order in which they were filed. Id.; see also CRD Dkt. Entry Nos. 16, 17, 17a-17d.
After discussing the parties’ evidence, I explained that I could either conduct a hearing or decide this case based on the written record. Id. at 3. I further explained that the sole purpose of a hearing would be to allow for the cross-examination of any witnesses that provided sworn direct testimony. Id. Respondent stated that it wished to cross-examine both of CTP’s witnesses: (a) Deputy Division Director James Bowling and (b) Inspector Francis D. Forney. Id. Accordingly, I stated that I would conduct a hearing and after the PHC concluded, I scheduled a hearing for October 9, 2025. CRD Dkt. Entry No. 29.
On October 9, 2025, at 11:00 AM Eastern Time, I conducted a virtual hearing, which was recorded and transcribed. CRD Dkt. Entry No. 30 (Hearing Transcript). At the hearing, I admitted CTP’s proposed exhibits 1-20 into the record after noting that Respondent did not file written objections as discussed at the PHC. Hearing Transcript (Hearing Tr.) 9:18-10:1. I also explained that the hearing would be limited to cross-examination and redirect examination, meaning no arguments or statements from the parties would be permitted. Hearing Tr. 10:3-10:8. Deputy Division Director James Bowling was then sworn in and presented for cross-examination. Id. 12:7-9. After being reminded that the scope of cross-examination was limited to Mr. Bowling’s written direct testimony, Respondent’s representative stated he had no questions for Mr. Bowling and Mr. Bowling was excused. Id. 12:20-13:22. Inspector Forney was then sworn in and cross-examined by Respondent before being excused. Id. 14:19-19:20.
On December 8, 2025, the transcript from the hearing was uploaded to the case docket. CRD Dkt. Entry No. 30. That same day, I issued an Order establishing deadlines for the parties to file any proposed corrections to the hearing transcript and to file post-hearing briefs. CRD Dkt. Entry No. 31.
On January 8, 2026, CTP timely submitted a notice indicating its waiver of a post-hearing brief. CRD Dkt. Entry No. 32. Respondent did not file a post-hearing brief.
Both parties had the opportunity to present evidence and testimony, cross-examine witnesses, and fully argue their respective positions. Accordingly, the administrative record is now closed, and this case is ready for a decision. 21 C.F.R. § 17.41; 21 C.F.R. § 17.45; 21 C.F.R. § 17.19(b)(11).
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II. Issues
A. Whether Respondent sold covered tobacco products to underage purchasers on September 21, 2023, and May 9, 2024, and failed to verify, by means of photographic identification, that the purchasers were 21 years of age or older, in violation of section 906(d)(5) the Act and 21 C.F.R. § 1140.14(b)(2)(i); and, if so,
B. Whether the $687 civil money penalty is appropriate, considering any mitigating or aggravating factors that I find in this case. 21 C.F.R. § 17.45.
III. Findings of Fact and Conclusions of Law
A. CTP has demonstrated by a preponderance of the evidence that the violations occurred as alleged in the complaint.
CTP seeks to impose a $687 penalty against Respondent pursuant to the authority conferred by the Act and implementing regulations at Part 21 of the Code of Federal Regulations. The burden is on CTP to prove Respondent’s liability and the appropriateness of any civil money penalty, including any aggravating circumstances, by a preponderance of the evidence. 21 C.F.R. § 17.33(b). The burden is on Respondent to prove any affirmative defenses and mitigating factors by a preponderance of the evidence. 21 C.F.R. § 17.33(c).
The Act prohibits the misbranding of a covered tobacco product while it is held for sale after shipment in interstate commerce, including “covered tobacco products,” such as cigars. 21 U.S.C. § 331(k). A covered tobacco product is defined as “any tobacco product deemed to be subject to the [Act] . . . but excludes any component or part that is not made or derived from tobacco.” 21 C.F.R. § 1140.3. A covered tobacco product is misbranded if it is sold or distributed in violation of section 906(d) of the Act (21 U.S.C. § 387f(d)) or regulations issued under section 906(d) of the Act (21 C.F.R. pt. 1140). 21 U.S.C. § 387c(a)(7)(B); 21 C.F.R. § 1140.1(b). Under section 906(d)(5) of the Act, no retailer may sell covered tobacco products to any person younger than 21 years of age or fail to verify, by means of photographic identification containing a purchaser’s date of birth, that no covered tobacco purchaser is younger than 21 years of age. 21 U.S.C. § 387f(d)(5); 21 C.F.R. § 1140.14(b)(2)(ii).
CTP may seek a civil money penalty against any person who violates any requirement of the Act or regulations concerning the sale of covered tobacco products by filing an administrative complaint. 21 U.S.C. §§ 333(f)(5), (f)(9); see also 21 C.F.R. §§ 17.1(j), 17.5(a). The Act and implementing regulations provide limitations on the amount of the penalty based on the number of violations within a specified timeframe. 21 U.S.C. § 333(f)(9); 21 U.S.C. § 333 note; 21 C.F.R. § 17.2; 45 C.F.R. § 102.3.
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In this case, CTP alleges that during two inspections of Respondent’s establishment on September 21, 2023, and May 9, 2024, Respondent committed at least three violations of the Act. CRD Dkt. Entry No. 1 ¶¶ 13-15. In support of these allegations, CTP submitted the written direct testimony of Inspector Francis D. Forney and Deputy Division Director James Bowling, as well as documents related to the inspections, including reports, photographs, and other materials. See CTP Exs. 2-20
In his written direct testimony, Inspector Forney testified that he conducted undercover buy inspections at Respondent’s establishment on September 21, 2023, and May 9, 2024, and that an underaged purchaser (UP) under the age of 21 accompanied him during each inspection. CTP Ex. 4. ¶¶ 7, 12. Inspector Forney testified that during the first inspection on September 21, 2023, at approximately 5:33 pm, he personally observed the UP purchase a package of Backwoods Honey Berry cigars directly from an employee at Respondent’s establishment without providing identification. Id. ¶ 8. Inspector Forney further testified that during the second inspection on May 9, 2024, at approximately 3:32 pm, he personally observed the UP purchase a package of Garcia Y Vega Game Mango cigars directly from an employee at Respondent’s establishment without providing identification. Id. ¶ 13. Inspector Forney’s testimony is supported by his narrative reports, photographs of the purchased products, notices of the inspections that were sent to Respondent, and redacted copies of the UPs’ state-issued identification showing they were under the age of 21 at the time of the sales. See CTP Exs. 5-18.
In his written direct testimony, Deputy Division Director Bowling testified that the FDA maintains a database called the Tobacco Registration and Listing Module Next Generation (TRLM NG), which collects and stores registration information of establishments engaged in the manufacture, preparation, compounding, or processing of tobacco products. CTP Ex. 3 ¶¶ 4-5. Mr. Bowling testified that a review of the TRLM NG database showed that the cigars purchased during both inspections of Respondent’s establishment were manufactured outside the state of Maryland, where Respondent operates. Id. ¶¶ 6-10. Mr. Bowling’s testimony is supported by printouts from the TRLM NG database showing the registration information for the manufacturers of the purchased products. CTP Exs. 19, 20.
In disputing its liability, Respondent claims, without evidence, that no tobacco products were sold on the “exact date and exact time” of the inspections. See CRD Dkt. Entry No. 6 at 4. Respondent further argues that there is no proof the inspections even occurred because Inspector Forney did not alert the business or issue a “ticket” at the time of the alleged violations. Id. at 6-7. According to Respondent, CTP should have immediately notified either the cashier or the manager and allowed them to “sign to acknowledge” the violations. Id.; see also CRD Dkt. Entry No. 3 at 1, 2.Respondent also claims CTP cannot issue a “fine and ticket” for multiple violations, as CTP could then just let “tickets pile up” and seek a penalty of “more than $5,000.” CRD Dkt. Entry No. 6 at 7. Finally,
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Respondent contends the cashier—not the business—should be responsible for the violations. CRD Dkt. Entry No. 3 at 2.
I am not persuaded by Respondent’s arguments. As an initial matter, Respondent has failed to present any evidence or identify any relevant laws or regulations to support its positions. Instead, Respondent relies entirely on conclusory statements and unsupported contentions, many of which conflict with the record and the applicable law. For example, Respondent’s unsubstantiated claim that no tobacco products were sold on the “exact” date and time of the inspections is directly contradicted by Inspector Forney’s sworn testimony, as well as the related written reports and photographs. See CTP Exs. 4, 5, 7, 10, 11, 15, 16. Respondent’s bald assertions are not sufficient to refute the testimony and evidence presented by CTP.
Moreover, Respondent’s claim that CTP’s inspector had an obligation to notify Respondent of any violations at the time of each inspection is unfounded. Nothing in the Act requires CTP to announce an undercover buy operation or alert the business immediately after the inspection occurs.3 Indeed, such a requirement would interfere with CTP’s ability to conduct covert inspections by enabling retailers to quickly and easily identify UPs and inspectors. It is also worth noting that CTP promptly notified Respondent of each violation. Specifically, CTP issued and delivered written notice of the alleged violations less than two weeks after each inspection occurred. CTP Exs. 12, 13, 17, 18. On October 17, 2023, CTP also issued a warning letter to Respondent which detailed the September 21, 2023 violations, outlined Respondent’s obligations under the Act, and warned that future violations could result in penalties and other enforcement actions. CTP Ex. 1. Therefore, I find no merit in Respondent’s suggestion that CTP failed to provide adequate notice of the violations in this case.
Further, Respondent’s contention that CTP cannot seek penalties for multiple violations is inconsistent with the law. The Act specifically authorizes CTP to seek penalties for multiple violations in a single proceeding and provides for increasing penalties based on the number of violations within a specified timeframe. See 21 U.S.C. § 333(f)(9)(A); 21 U.S.C. § 333 note; 21 C.F.R. § 17.2; 45 C.F.R. § 102.3. As noted above, CTP also warned Respondent in writing after the first inspection that additional violations may result in penalties, with citations to the relevant statutory and regulatory provisions. CTP Ex. 1. Thus, I find that CTP is authorized to seek penalties for multiple violations and Respondent was specifically notified of this fact. Finally, Respondent’s claim that the cashier should be personally responsible for any penalties reflects a fundamental misunderstanding of Respondent’s obligations under the
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Act. As a retailer that has chosen to sell heavily regulated tobacco products for profit, Respondent is responsible for ensuring its employees understand and comply with the applicable law. Respondent cannot neglect its obligations and then shift the liability for any resulting violations to its employees.
In sum, I find that Respondent has failed to present any evidence refuting the testimony and evidence presented by CTP. I also find that the arguments and positions outlined in Respondent’s filings are unsupported by the facts or the law. Therefore, I conclude that Respondent has failed to assert any valid defense or other basis for overcoming a finding of liability in this case.
Based on the uncontroverted evidence and testimony presented by CTP, I find by a preponderance of the evidence that during the inspections on September 21, 2023 and May 9, 2024, Respondent sold covered tobacco products to persons under the age of 21 years in violation of section 906(d)(5) of the Act and, on both occasions, also failed to verify the age of the purchasers by means of photographic identification in violation of 21 C.F.R. § 1140.14(b)(2)(i). Therefore, I conclude that Respondent committed at least three violations of the Act within a 24-month period and is subject to a civil money penalty. See 21 U.S.C. §§ 333(f)(5), (f)(9); see also 21 C.F.R. §§ 17.1(j), 17.5(a).
B. The $687 penalty requested by CTP is appropriate.
Having found Respondent liable for the violations alleged in the complaint, I now must determine whether the civil money penalty requested by CTP is appropriate. In evaluating the appropriateness of the penalty, I am required to consider any “circumstances that mitigate or aggravate the violation” by referring to “the factors identified in the statute under which the penalty is assessed . . . .” 21 C.F.R. § 17.34(a), (b). Specifically, I must consider “the nature, circumstances, extent and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require.” 21 U.S.C. § 333(f)(5)(B).
Here, CTP is requesting a penalty in the amount of $687 for at least three violations of the Act within a 24-month period, which is the maximum penalty under the Act. See CRD Dkt. Entry No. 1 ¶ 1; see also 21 U.S.C. § 333(f)(9)(A); 21 U.S.C. § 333 note; 21 C.F.R. § 17.2; 45 C.F.R. § 102.3. For the reasons stated below, after considering the statutory factors identified above, I conclude that the requested penalty is appropriate and warranted in this case. See 21 C.F.R. §§ 17.33(a), (c); 17.34(a)-(c).
1. Nature, Circumstances, Extent, and Gravity of the Violations
The Family Smoking Prevention and Tobacco Control Act was enacted for the purpose of authorizing regulation of tobacco products for the “protection of the public health.” 21
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U.S.C. § 387f(d). There is no dispute that Respondent was in the business of selling a highly regulated and dangerous product. See generally 21 U.S.C. § 387 note (Findings and Purpose).
CTP contends the violations in this case are particularly serious because CTP previously issued a warning letter to Respondent on October 17, 2023, in connection with the September 21, 2023 violation. CTP Br. at 15; see also CTP Ex. 1. In the letter, CTP notified Respondent of the violation and warned that any future violations could result in a civil money penalty action or other action by FDA. CTP Ex. 1 at 2. CTP argues that by committing additional violations after being warned about its conduct, Respondent has demonstrated an unwillingness or inability to correct its violations. CTP Br. at 15.
Respondent, on the other hand, has not directly responded to CTP’s arguments concerning the penalty amount or otherwise identified any factors that might mitigate the nature, circumstances, extent, or gravity of the violations. Nevertheless, I note that Respondent did submit photographs of signage displayed in its establishment warning against selling tobacco products to purchasers under 21 years of age, which could be construed as a potentially mitigating factor. R. Exs. 2-6.
After considering the parties’ submissions and arguments, I agree with CTP that the violations in this case are particularly serious. As discussed above, the record shows Respondent committed several violations of the Act within a relatively short timeframe. Further, the warning letter shows that despite being warned about its conduct after the first violations, Respondent committed the exact same type of violations less than eight months later. I also find that the signage in Respondent’s establishment is not adequate on its own to mitigate the violations given the more serious aspects of this case, including the warning letter and the number of violations. Therefore, I conclude that the nature, circumstances, extent, and gravity of the violations weigh in favor of imposing the requested penalty amount.
2. Respondent’s Ability to Pay and Effect on Ability to Do Business
Respondent has not claimed an inability to pay the requested penalty, nor is there any evidence that imposing the requested penalty would negatively impact Respondent’s ability to continue doing business. In fact, Respondent’s 2023 business tax return shows Respondent operates a profitable business, with gross receipts totaling $683,269 and an ordinary business income of $29,317 after all claimed deductions, expenses, and salaries. R. Ex. 1. Under the circumstances, I find that the requested $687 penalty would not impose any financial hardship on Respondent or otherwise interfere with its business operations. Therefore, I find no reason to reduce the requested penalty on this basis.
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3. History of Prior Violations
CTP argues that Respondent’s repeated violations demonstrate an “unwillingness or inability to sell tobacco products in accordance with federal tobacco laws.” CTP Br. at 15. I agree and find that Respondent’s violation history is significant. As discussed above, the record shows Respondent violated the Act at least three times in less than eight months, despite being warned about its conduct after the initial inspection. I also note that Respondent has not identified any clear steps it has taken to reduce the likelihood of future violations. Therefore, I conclude that this factor weighs in favor of imposing the requested penalty amount.
4. Degree of Culpability
Based on my finding that Respondent committed the violations alleged in the complaint, I hold Respondent fully culpable for its violation of the Act. The Act places a heavy burden on retailers who choose to sell tobacco products because of their highly dangerous and addictive nature. See 21 U.S.C. § 387 note (Findings and Purpose). I also find that Respondent’s claim that its employees should be personally responsible for the violations demonstrates a lack of accountability and a fundamental misunderstanding of Respondent’s obligations as a retailer of tobacco products. In my view, this position casts doubt on Respondent’s willingness or ability to ensure its employees comply with the Act in the future. Therefore, I conclude that this factor weighs in favor of imposing the requested penalty amount.
5. Other Matters as Justice may Require
As explained above, Respondent bears the burden of proving any mitigating factors by a preponderance of the evidence. 21 C.F.R. § 17.33(c). Based on the arguments presented by Respondent, I find that Respondent has not identified or otherwise established any other potentially mitigating factors for me to consider in this case.
In sum, after considering the record evidence, the applicable law, and all relevant factors, I find that requested penalty of $687 is warranted and appropriate under 21 U.S.C. §§ 333(f)(5)(B), (f)(5)(C), and (f)(9).
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IV. Conclusion
For the reasons stated above, I impose a civil money penalty against Respondent, Infinity Petroleum, Inc. d/b/a Shell / Snack Shop, in the amount of $687 for three violations of the Act within a 24-month period. Pursuant to 21 C.F.R. § 17.45(d), this order becomes final and binding upon both parties after 30 days of the date of its issuance.
Adam R. Gazaille Administrative Law Judge
- 1
CTP alleges two violations were committed on September 21, 2023, and two on May 9, 2024. In accordance with customary practice, CTP counted the violations at the initial inspection as a single violation, and all subsequent violations as separate individual violations. See Orton Motor, Inc. d/b/a Orton’s Bagley v. U.S. Dep’t of Health & Human Serv., 884 F.3d 1205 (D.C. Cir. 2018).
- 2
Respondent filed duplicate copies of its pre-hearing brief.
- 3
On cross-examination, Inspector Forney testified that for “undercover purchaser” inspections, he does not announce himself or alert the business but instead observes the UP, documents the inspection with evidence and photographs, and then reports the results to CTP. Hearing Tr. 17:7-18:2.