FDA 483 - Cydmax (India) Pharma Private Limited - March 24, 2023

An FDA inspection conducted at PharmaSolutions Inc. from March 13 to March 24, 2023, identified significant deviations from Current Good Manufacturing Practice (cGMP) regulations. The observations, detailed in an FDA Form 483, indicate critical deficiencies in quality control and manufacturing processes. Key issues included a lack of adequate validation for the sterilization process of sterile drug products, specifically for an aseptic filling line. The media fill simulation for an injectable product did not simulate 'worst-case' conditions, such as operator interventions, a deficiency noted in a previous inspection, violating 21 CFR 211.113(b). Furthermore, the company was cited for releasing batches of a tablet product without completing required assay and dissolution testing, as mandated by their own standard operating procedures and 21 CFR 211.165(a). This indicates a failure in proper laboratory determination prior to product release. The inspection also revealed inadequate investigations into product discrepancies, where an out-of-specification result for content uniformity lacked a definitive root cause, supporting data, or an expanded investigation into other potentially affected batches. This non-compliance with 21 CFR 211.192 requires thorough and documented investigations. PharmaSolutions Inc. is expected to promptly address these observations by implementing comprehensive corrective and preventive actions to ensure full compliance with FDA regulations and safeguard product quality and patient safety.