FDA 483 - The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group - May 06, 2022

The Micro Connection Enterprises dba Personal Care Performance received a Form 483 citing significant deficiencies across its quality system and laboratory operations. Observations included severe data integrity issues with electronic records, inadequate quality control unit oversight and complaint investigations, and critical failures in water system validation and monitoring. The firm also failed to conduct proper annual product quality reviews and lacked scientifically sound laboratory controls for API testing and growth promotion.