FDA 483 - Srikem Laboratories Pvt. Ltd. - May 31, 2024

An FDA inspection of Srikem Laboratories Pvt. Ltd., an Active Pharmaceutical Ingredient manufacturer, conducted from May 27-31, 2024, identified eleven significant observations indicating widespread non-compliance with Good Manufacturing Practices. The core issues revolved around severe deficiencies in documentation and the Quality Control Unit's oversight. Inspectors observed pervasive poor documentation practices, including unofficial procedures, uninitialed and undated record alterations, and discrepancies between in-process testing and batch manufacturing records. This was a repeat observation, underscoring systemic problems. Crucially, the firm's investigations into Out-of-Specification (OOS) results were repeatedly found to be scientifically unsound and lacked comprehensive root cause analysis or effective corrective and preventive actions (CAPAs). Alarmingly, materials subject to ongoing, inadequate OOS investigations were subsequently used in manufacturing, and the finished Active Pharmaceutical Ingredients were released to market. Laboratory control procedures were also notably deficient, with a substantial backlog of unperformed and unreviewed stability testing, incomplete records, and questionable data integrity in environmental monitoring. Additional concerns included inadequate facility and equipment maintenance, missing process validation records, and critical omissions in component testing, such as for water quality. A particularly serious observation was the failure to provide requested documents and the apparent misrepresentation of records during the inspection, highlighting a lack of transparency and control. Srikem Laboratories is required to address these systemic issues comprehensively to ensure compliance with regulatory standards and safeguard product quality.