Gordon Laboratories Inc.

Warning LetterOpen

Ms. Julia A. Christiansen Chief Executive Officer Gordon Laboratories Inc. 751 E Artesia Blvd Carson , CA 90746 United StatesFEI 2012546Issued Aug 17, 2022Division of Pharmaceutical Quality Operations IV

View Letter

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 2012546.

Violations5

Issue DateAug 17, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Gordon Laboratories Inc.
Location: Ms. Julia A. Christiansen Chief Executive Officer Gordon Laboratories Inc. 751 E Artesia Blvd Carson , CA 90746 United States
FEI Number: 2012546
Country: United States
Issue Date: August 17, 2022
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

Gordon Laboratories Inc. manufactured adulterated artnaturals SCENT FREE HAND SANITIZER products that contained unacceptable levels of benzene impurities (approximately 15 ppm) along with acetaldehyde and acetal impurities. An FDA inspection of the facility from February to March 2022 identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, finding that the company's methods, facilities, and controls for manufacturing, processing, packing, and holding did not meet regulatory standards. The violations rendered the distributed hand sanitizer products adulterated under the Federal Food, Drug, and Cosmetic Act.

Gordon Laboratories Inc. FDA Warning Letter, August 17, 2022