Cergomex Imports, LLC

Warning LetterOpen

Mr. Victor Hugo Cerrillo Gonzalez Owner Cergomex Imports, LLC 8524 Crownwood Drive Laredo , TX 78045 United StatesFEI 3017539604Issued Aug 4, 2023Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3017539604.

Violations1

Issue DateAug 4, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: Cergomex Imports, LLC
Location: Mr. Victor Hugo Cerrillo Gonzalez Owner Cergomex Imports, LLC 8524 Crownwood Drive Laredo , TX 78045 United States
FEI Number: 3017539604
Country: United States
Issue Date: August 04, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

Cergomex Imports, LLC, a manufacturer of OTC drug products including Sanetto Hands Sanitizer Gel, failed to respond to FDA records requests sent via email on August 16 and August 31, 2022, and subsequent phone contact attempts in October 2022 and August 2023. The company's refusal to provide access to and copying of records as required under section 704(a) of the Federal Food, Drug, and Cosmetic Act constituted a prohibited act under section 301(e) of the FD&C Act. Without access to these records, the FDA had no way to assess the quality assurance levels for drugs manufactured at the facility. The FDA directed the company to respond within 48 hours confirming its registration status and willingness to comply with the records request, or to delist all drugs and deregister its facility if manufacturing had ceased.

Cergomex Imports, LLC FDA Warning Letter, August 4, 2023