Cergomex Imports, LLC – FDA Warning Letter, Aug 8, 2023

This FDA Warning Letter, dated August 4, 2023, was issued to Mr. Cerrillo Gonzalez, whose firm is registered as an OTC drug product manufacturer, specifically of Sanetto Hands Sanitizer Gel. The letter stems from the firm's failure to respond to multiple electronic requests for records and information, initiated on August 16, 2022, and August 31, 2022, under section 704(a)(4) of the FD&C Act. Subsequent phone attempts by the FDA on October 24, 2022, and August 1, 2023, also went unanswered.

The refusal to permit access to or copying of records as required by section 704(a) is cited as a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)). Due to the firm's non-response, the FDA has no indication of the quality assurance level for drugs manufactured at the facility.

The letter requires a response within 48 hours to confirm or update registration and/or drug listing status and to indicate whether the firm will respond to the records request. If drug manufacturing has ceased, the firm must delist all drugs and deregister the facility. The FDA may conduct an inspection to verify information or evaluate compliance. Continued non-response regarding quality