FDA 483 - Universal Packaging Systems, Inc. dba PakLab - May 29, 2025

An FDA inspection of Universal Packaging Systems, Inc., a contract OTC drug product manufacturer in Chino, CA, revealed significant deficiencies across multiple systems. The firm was cited for issues including an inadequate quality control unit, a deficient stability program, pre-entering production data, improper warehousing of rejected materials, and unclean equipment. These observations indicate a lack of adherence to Good Manufacturing Practices.