Aerosol and Liquid Packaging, Inc.

Warning LetterOpen

Mr. Lee E. Jay, Jr. President Aerosol and Liquid Packaging, Inc. 3701-A Southwestern Blvd. Ste. 100 Baltimore , MD 21229-5030 United States lee@alpackaging.comFEI 1120890Issued Jul 24, 2024Division of Pharmaceutical Quality Operations I

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 1120890.

Violations6

Issue DateJul 24, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Aerosol and Liquid Packaging, Inc.
Location: Mr. Lee E. Jay, Jr. President Aerosol and Liquid Packaging, Inc. 3701-A Southwestern Blvd. Ste. 100 Baltimore , MD 21229-5030 United States lee@alpackaging.com
FEI Number: 1120890
Country: United States
Issue Date: July 24, 2024
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

Aerosol and Liquid Packaging, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of over-the-counter drug products, including a topical antiseptic spray, making their finished pharmaceuticals adulterated under federal law. The company failed to conduct required identity testing for drug components and did not validate or establish the reliability of their component suppliers' test analyses at appropriate intervals. Additionally, the firm did not adequately test incoming active pharmaceutical ingredients and other components despite contract manufacturing OTC drug products. The company's unapproved drug product was also found to be introduced into interstate commerce in violation of federal law and was determined to be misbranded.

Aerosol and Liquid Packaging, Inc. FDA Warning Letter, July 24, 2024