FDA 483 - DPT Laboratories Ltd - February 10, 2026
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An FDA inspection of DPT Laboratories Ltd in San Antonio, TX, revealed significant deficiencies in the manufacturing processes for aerosol drug products. The firm failed to adequately validate in-process packaging controls, particularly the leak detection process, and did not ensure routine production practices aligned with validation criteria. Additionally, the company lacked adequate written procedures for production and process controls, impacting product identity, strength, purity, and quality.
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