FDA 483 - Anthea Pharma Private Limited - December 22, 2025

An FDA inspection conducted between December 12 and December 22, 2025, at Anthea Pharma Private Limited in Sangareddy, Telangana, India, identified significant deviations from Current Good Manufacturing Practices (cGMP). The inspection resulted in an FDA Form 483, outlining multiple concerns regarding the company's manufacturing and quality control systems for drug products. Primary observations included deficiencies in equipment qualification, where critical machinery such as compounding vessels and vial labeling machines lacked adequate performance studies or failed to meet established specifications. The firm was also cited for failing to investigate out-of-specification yield variations during drug product production, indicating a lapse in discrepancy review procedures. The Quality Control unit exhibited several weaknesses, including inconsistent batch yield reporting, errors in official reports, and the premature destruction of samples involved in active investigations. Additional issues encompassed inadequate laboratory controls, such as inappropriate lighting for visual inspections and insufficient training for inspectors to detect specific defects. Controls to prevent microbiological contamination in sterile processes were found lacking, particularly concerning media traceability. Furthermore, production and process control procedures lacked clearly defined acceptance criteria in qualification protocols, and theoretical yield limits were absent from batch records. Finally, a critical concern involved inadequate controls over computer systems, specifically chromatography software, which allowed analysts to view results before final processing, raising data integrity questions. Anthea Pharma Private Limited is expected to implement comprehensive corrective and preventive actions to resolve these deficiencies and ensure compliance with regulatory standards for drug product safety, quality, and efficacy.