FDA 483 - LabChemS Corp. - February 08, 2024

LabChemS Corp., a contract testing laboratory in Mayaguez, PR, was cited for significant deficiencies during an FDA inspection. Observations included a lack of quality control unit responsibility, inadequate data integrity controls with uncontrolled access to laboratory equipment and expired reagents, and a failure to provide current Good Manufacturing Practice (cGMP) training to Quality Unit employees. These issues indicate a systemic breakdown in quality assurance and compliance.