Quality Observations in Form 483 Earn Maryland Company Warning Letter as Well

A 10-item Form 483 called out multiple problems with expired or non-pharmaceutical grade products, lack of written procedures and records, and an inadequate quality control unit at Maryland-based Aerosol and Liquid Packaging.

The firm received a follow-up warning letter from the FDA, but all the issues in the 483 have been addressed, according to Kevin Brown, the company’s quality control manager.

The 483 arose from an inspection in December 2023. According to the investigator, the company used both an expired lot and a non-pharmaceutical grade product to create a finished drug product.

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