FDA 483 - LabChemS Corp. - February 08, 2024

During an inspection conducted from February 6-8, 2024, the FDA issued a Form 483 to LabChemS Corp., a contract testing laboratory located in Mayaguez, PR. The inspection revealed significant deficiencies primarily related to the firm's quality system and employee training, indicating non-compliance with Current Good Manufacturing Practices (cGMP) as outlined in the Federal Food, Drug and Cosmetic Act. Key observations included a lack of proper control within the quality control unit, which failed to adequately approve or reject procedures affecting drug product quality. Specifically, the firm's data integrity was compromised by insufficient access controls on laboratory equipment, where analysts held administrator rights allowing potential data modification or deletion. Furthermore, the firm used expired reagents for equipment calibration and exhibited inadequate contemporaneous documentation practices. There was also an absence of written operational and preventive maintenance procedures for critical laboratory equipment. Additionally, LabChemS Corp. failed to provide sufficient cGMP training to its Quality Unit employees, despite client agreements requiring adherence to cGMP standards and a prior commitment to the FDA regarding refresher training. To address these issues, LabChemS Corp. must implement robust corrective actions, including enhancing quality control oversight, strengthening data integrity measures, developing comprehensive written procedures for equipment and documentation, and establishing a thorough cGMP training program for all relevant personnel.