Yusef Manufacturing Laboratories, LLC

Warning LetterOpen

Mr. Fielding R. Smith President Yusef Manufacturing Laboratories, LLC Freeport West, F-4, #3 PO Box 160347 Clearfield , UT 84016 United StatesFEI 3004845420Issued Feb 8, 2022Division of Pharmaceutical Quality Operations IV

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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 3004845420.

Violations6

Issue DateFeb 8, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Yusef Manufacturing Laboratories, LLC
Location: Mr. Fielding R. Smith President Yusef Manufacturing Laboratories, LLC Freeport West, F-4, #3 PO Box 160347 Clearfield , UT 84016 United States
FEI Number: 3004845420
Country: United States
Issue Date: February 08, 2022
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

Yusef Manufacturing Laboratories, LLC received this warning for manufacturing adulterated over-the-counter drug products, including hand sanitizers, due to significant Current Good Manufacturing Practice (CGMP) violations. The company failed to conduct required identity tests on incoming components and did not validate or establish the reliability of supplier test analyses at appropriate intervals, instead relying solely on unqualified suppliers' certificates of analysis. Specifically, the firm accepted ethanol for hand sanitizer manufacturing based only on visual and olfactory inspection without performing adequate testing for identity, purity, strength, and quality. These failures meant the company could not ensure that incoming components met appropriate specifications, rendering their finished drug products adulterated under federal law.

Yusef Manufacturing Laboratories, LLC FDA Warning Letter, February 8, 2022