Cetylite Industries, Inc.

Warning LetterOpen

Mr. Gary L. Wachman President Cetylite Industries, Inc. 9051 River Road Pennsauken , NJ 08110 United StatesFEI 2242327Issued Apr 14, 2022Division of Pharmaceutical Quality Operations I

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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 2242327.

Violations2

Issue DateApr 14, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Cetylite Industries, Inc.
Location: Mr. Gary L. Wachman President Cetylite Industries, Inc. 9051 River Road Pennsauken , NJ 08110 United States
FEI Number: 2242327
Country: United States
Issue Date: April 14, 2022
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

Cetylite Industries, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in manufacturing finished pharmaceutical drugs, specifically Cetacaine Mint Gel Topical Anesthetic. The company failed to establish appropriate laboratory controls and specifications for testing components and finished products, and improperly used a compendial testing method for aerosol formulations instead of the required method for gel formulations without proper validation. The firm's corrective action response to the FDA's initial inspection findings was deemed inadequate due to insufficient detail and evidence of compliance measures.

Cetylite Industries, Inc. FDA Warning Letter, April 14, 2022