Inopak, Ltd.

Warning LetterOpen

Mr. Lester Sampath Chief Executive Officer Inopak, Ltd. 24 Executive Pkwy Ringwood , NJ 07456 United States lester@inopak.comFEI 1000122232Issued Dec 15, 2023Division 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 1000122232.

Letter Details

Firm: Inopak, Ltd.
Location: Mr. Lester Sampath Chief Executive Officer Inopak, Ltd. 24 Executive Pkwy Ringwood , NJ 07456 United States lester@inopak.com
FEI Number: 1000122232
Country: United States
Issue Date: December 15, 2023
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

Inopak, Ltd. received a warning letter for adulterated OTC drug products, specifically SaniGuard SF foam hand sanitizer, due to significant Current Good Manufacturing Practice (CGMP) violations at their Ringwood, New Jersey facility. The company failed to establish an adequate quality unit with documented responsibilities and procedures, and critically, did not properly review critical documentation from their contract manufacturer including formulations, batch records, and certificates of analysis to verify required testing for methanol and acceptable levels of impurities like benzene, acetaldehyde, and acetal in ethanol components. These deficiencies rendered their drug products adulterated under federal law, violating 21 CFR parts 210 and 211. The FDA inspection occurred from July 24 to August 3, 2023, following which the company submitted a response on August 24, 2023.