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Warning Letter 320-23-40

September 19, 2023

Dear Mr. Sargisian:

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 included (b)(4). On September 27, 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 email address provided in your registration file. This request went unanswered, as did a second email request sent on October 12, 2022. An FDA representative then attempted to contact your firm by phone on December 8, 2022, but was unable to leave a message. A second attempt to contact you at the phone number listed on your website was made on December 14, 2022, but the number listed did not provide an opportunity to leave a voicemail. The Agency then sent a follow-up written request for such records and other information via UPS that was delivered to the physical address provided in your registration file on February 7, 2023. Delivery to you was confirmed by the shipper, but you failed to respond. We made a final attempt to contact you by phone on September 15, 2023, but received various automated messages indicating that 833-773-7587 is no longer in service. Pursuant to section 704(a)(4), FDA’s request for records 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 OTC drug firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.¹

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.

(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 3017242852 and ATTN: Rokhsana Jazi.

Sincerely,
/S/

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

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1 (b)(4)