FDA 483 - Universal Packaging Systems, Inc. dba PakLab - November 17, 2023

An FDA inspection of Universal Packaging Systems, Inc. dba Paklab in Chino, CA, an OTC drug contract manufacturer, revealed significant deficiencies across its production, quality, and laboratory systems. Key issues included inadequate water system validation, insufficient investigations into out-of-specification results and microbial contamination, and failures in laboratory controls and equipment cleaning procedures. These findings indicate a lack of adherence to good manufacturing practices, potentially impacting the quality and purity of drug products.