FDA 483 - Serum Institute of India Pvt. Ltd. - April 19, 2022

An FDA 483 report was issued to Serum Institute of India Pvt. Ltd. following an inspection conducted from April 11 to April 19, 2022. The document outlines significant deficiencies indicating potential non-compliance with regulatory standards for biological manufacturers.

Key observations highlight pervasive issues with Good Documentation Practices and data integrity, including numerous deviations related to typographical errors in master records, improper logbook entries, and misplaced audit trails. Deficiencies were also noted in a critical detection method, with inadequate controls and inaccurate interpretation instructions. The inspection found a lack of data supporting the potency of reference standards and highlighted instances where batches were manufactured using unvalidated processes, deviating from established methods.

Further concerns include inadequate reporting and investigation of deviations, such as inconsistent categorization, incomplete root cause analyses, and untimely product impact assessments. Lapses in equipment maintenance were observed, including omitted HEPA filter replacement schedules and incomplete cleaning after preventive maintenance, which led to a batch failing endotoxin testing. Environmental monitoring in aseptic processing areas was found deficient, and corrective actions for previous issues were not completed promptly. Additionally, aseptic fill validation did not adhere to its protocol.

Serum Institute is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with current Good Manufacturing Practices, thereby safeguarding product quality and patient safety.