FDA 483 - The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group - October 30, 2019

An FDA inspection of The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group in City Of Industry, CA, revealed significant deficiencies in the manufacturing of OTC drug products. The firm was cited for multiple repeat observations, including failures in stability testing, laboratory controls, electronic record management, production and process controls, and annual product reviews. These issues indicate a broad lack of adherence to good manufacturing practices.