Cergomex Imports, LLC

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Warning Letter 320-23-31

August 4, 2023

Dear Mr. Cerrillo Gonzalez:

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 including Sanetto Hands Sanitizer Gel. On August 16, 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. A second email request was sent on August 31, 2022. These requests went unanswered. FDA contacted you by phone on October 24, 2022, and requested that you provide a response by October 31, 2022. We made multiple attempts to contact you by phone on August 1, 2023. Those attempts were unsuccessful and we were unable to leave a voice message. 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 the Agency’s list of hand sanitizers consumers should not use, at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use.

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 3017539604 and ATTN: Joel Hustedt.

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

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1 Since declaration of the COVID-19 public health emergency, a number of hand sanitizer 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 hand sanitizers included in their product listing, to assess the overall quality of the drugs registered as manufactured by these firms.