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Warning Letter 320-23-37

September 12, 2023

Dear Mr. Holmes:

Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products listed include (b)(4). On September 9, 2022, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered, as did another email request sent on September 27, 2022. On October 3, 2022, you sent an email acknowledging FDA’s request, but did not respond to the 704(a)(4) request. FDA attempted to contact you by phone on November 16, 2022, and left a voicemail requesting that you provide a response by October 31, 2022. FDA also attempted to contact you by phone on September 6, 2023, and left a voicemail with your firm requesting a response within 24 hours. You failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.

It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).

Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts,¹ we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.

Respond to this letter within 48 hours to confirm or update your registration and/or drug listing status and indicate whether you will respond to the request for records and other information. If you are no longer manufacturing drugs, delist all the drugs previously listed with FDA, using the last lot expiration date as the marketing end date of the product, and deregister your facility accordingly.

The Agency may conduct an inspection to verify information provided and/or to evaluate the compliance of your manufacturing operations.

Continued non-response regarding questions of the quality assurance of the drugs manufactured at your facility may lead to inclusion on (b)(4).

You may provide additional information for our consideration as we continue to assess your activities and practices.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov.

Identify your response with FEI 3007520648 and ATTN: Rory Geyer.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research, FDA

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1 During the COVID-19 public health emergency, which expired on May 11, 2023, a number of (b)(4) products have been recalled due to quality issues including from substitution with other drug substances, impurities at unacceptable levels, and subpotency. The Agency has reached out to registered OTC drug firms with (b)(4) included in their product listing, to assess the overall quality of the drugs registered as manufactured by these firms.