Avlon Industries, Inc.

Warning LetterOpen

Dr. Ali N. Syed Co-President/Chairman Avlon Industries, Inc. 1999 N. 15th Avenue Melrose Park , IL 60160 United StatesFEI 3007090726Issued Jul 18, 2023Division of Pharmaceutical Quality Operations III

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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 3007090726.

Violations4

Issue DateJul 18, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Avlon Industries, Inc.
Location: Dr. Ali N. Syed Co-President/Chairman Avlon Industries, Inc. 1999 N. 15th Avenue Melrose Park , IL 60160 United States
FEI Number: 3007090726
Country: United States
Issue Date: July 18, 2023
Issuing Office: Division of Pharmaceutical Quality Operations III
Product Type: Drugs
Status: Open

Summary

Avlon Industries, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of over-the-counter (OTC) drug products at its Melrose Park, Illinois facility during a January 2023 inspection. The company failed to conduct identity testing on incoming components (including active ingredients, glycerin, and water) prior to manufacturing and improperly relied on unqualified suppliers' certificates of analysis instead of independently verifying component specifications for purity, strength, and quality. The firm's February 2023 response to the warning was deemed inadequate due to insufficient detail and evidence of corrective actions necessary to achieve CGMP compliance.

Avlon Industries, Inc. FDA Warning Letter, July 18, 2023