FDA 483 - Chromo Laboratories India Private Limited - August 10, 2024

An FDA inspection of Chromo Laboratories India PVT. LTD., an Intermediate and API Manufacturer, conducted from August 5-10, 2024, identified significant deficiencies in their quality systems and manufacturing operations. The firm received a Form FDA 483 detailing nine observations indicating non-compliance with Good Manufacturing Practices.

Key issues highlighted include a systemic failure to thoroughly investigate and trend Out-of-Specification (OOS) results, laboratory incidents, and customer complaints, preventing proper root cause identification and recurrence prevention. The Quality Unit demonstrated inadequate oversight, failing to comprehensively review deviations, facility/equipment failures, and parts changes for potential product impact.

Observations also noted poor equipment and facility maintenance, with chemical residues and corrosion found on manufacturing equipment and cleanroom surfaces, raising concerns about cross-contamination. Quality Control laboratory instruments, stability chambers, and incubators were not properly maintained or monitored. Furthermore, the firm exhibited deficient control over both hardcopy and electronic GMP records, lacking reconciliation, proper auditing, and effective data management procedures. Batch records contained errors, and the batch numbering system was inadequate.

Critical production and storage areas for intermediates and APIs lacked appropriate environmental controls, with observed humidity levels exceeding acceptable limits without scientific justification. Finally, employee training was found to be insufficient, with a significant portion of personnel not receiving required or routine GMP and good documentation practices training. Chromo Laboratories India PVT. LTD. is expected to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards.