FDA 483 - MICROTROL STERILISATION SERVICES PRIVATE LIMITED - December 13, 2023

The FDA conducted an inspection of Microtrol Sterilisation Services Private Limited, a contract sterilization organization located in Gurgaon, Haryana, India, from December 13 to December 19, 2023. The inspection revealed significant compliance issues primarily related to the absence of a quality control unit and deficiencies in data integrity and documentation practices.

Key violations included the lack of a dedicated Quality Assurance (QA) and Quality Control (QC) unit, which is essential for ensuring compliance with current Good Manufacturing Practices (cGMP). The firm failed to maintain accurate and reliable data, as evidenced by the improper handling and destruction of original quality-related documents. Observations highlighted that critical data was recorded on "rough papers" and subsequently discarded, undermining data integrity.

Additionally, the inspection noted discrepancies in record-keeping, such as non-contemporaneous completion of batch records and unauthorized transcription of data. The firm also lacked effective document control, with quality-related documents not being properly issued or maintained by the quality unit. Furthermore, the facility failed to implement change controls or conduct risk analyses when making changes, such as during facility renovations, which posed potential risks to product safety and quality.

The FDA requires Microtrol Sterilisation Services to establish a robust quality control unit, ensure accurate and secure handling of all quality-related data, and implement comprehensive document control and change management procedures. Immediate corrective actions are necessary to address these deficiencies and ensure compliance with regulatory standards.