DPT Laboratories Ltd – FDA 483, Feb 10, 2026

DPT Laboratories Ltd, a drug product manufacturer in San Antonio, TX, was cited for significant deficiencies in its manufacturing process controls and validation, particularly concerning the leak detection process for aerosol drug products. The firm failed to adequately validate its packaging controls and maintain consistent routine production practices, leading to concerns about container-closure integrity and product quality. Additionally, the company lacked adequate written procedures and objective criteria in its SOPs and master batch records for visual inspection and leak detection.