FDA 483 - ABBE Laboratories, Inc. - February 27, 2025

During an inspection from February 24-27, 2025, an unspecified pharmaceutical firm received an FDA Form 483 detailing significant deviations from regulatory standards. The inspection highlighted several critical issues. Firstly, the firm failed to adequately validate the reliability of component suppliers' analyses, specifically for Propylene Glycol and Glycerin, and neglected to test these raw materials for harmful diethylene glycol and ethylene glycol impurities, which were used in numerous over-the-counter (OTC) drug products. Secondly, written procedures for equipment cleaning and maintenance were deficient, lacking proper cleaning validation, re-validation, verification studies for shared manufacturing equipment, and failing to maintain required cleaning logbooks. Thirdly, the firm lacked established written procedures for production and process controls, including essential process validation for OTC drug manufacturing and packaging, and had no scientific rationale to support bulk hold times. Fourthly, the Quality Control Unit exhibited significant procedural gaps, lacking written procedures for deviation investigations and corrective and preventative actions (CAPA), and failing to fully adhere to established product release protocols. Finally, the firm did not follow its own written procedures for periodic evaluations of drug products, with no such reviews completed since 2016. The firm is required to promptly address these observations to ensure compliance with the Federal Food, Drug, and Cosmetic Act.