FDA 483 - Yash Pharmaceuticals - December 06, 2024

During an inspection conducted by the FDA from December 2-6, 2024, Yash Pharmaceuticals in Roorkee, Uttarakhand, India, received a Form 483 detailing significant observations concerning their operational and quality control processes. The inspection highlighted two primary areas of concern. Firstly, the firm lacked appropriate controls over computer systems, specifically failing to safeguard test data from an FT-IR instrument, used for raw material identification, from potential deletion, indicating a data integrity vulnerability. Secondly, the responsibilities and procedures of the quality control unit were found to be inadequately documented. Deficiencies included an incomplete written procedure for data review, which lacked comprehensive verification steps for HPLC analysis. Furthermore, the procedures for system suitability tests were insufficient, failing to provide clear instructions for manual integration of chromatographic peaks, including requirements for scientific justification, management approval, and proper logging. Finally, the HPLC operating procedure was deemed inadequate for not outlining guidelines for handling trial or single injections, such as naming conventions, scientific rationale, and limits on their use. Yash Pharmaceuticals is expected to implement robust corrective and preventive actions to address these observations and ensure compliance with good manufacturing practices.