FDA 483 - Global Pharma Healthcare Pvt. Ltd. - March 02, 2023

During an inspection in February 2023, the FDA issued a Form 483 to an unnamed pharmaceutical manufacturer, citing significant deviations from Current Good Manufacturing Practices (cGMP). The primary concerns centered on inadequate sterility assurance for various drug products, including (b)(4) mg/mL and (b)(4) Ointment, which were distributed to the U.S. market.Key violations included a lack of validation for sterilization processes, specifically (b)(4) filtration, and unvalidated filter integrity tests. The firm failed to conduct proper container closure integrity testing and maintain adequate aseptic process simulations (media fills), which did not reflect routine production conditions. Deficiencies were also noted in environmental and personnel monitoring, cleaning and disinfection procedures for aseptic areas, and the qualification of cleanroom operators.Furthermore, the inspection revealed issues with component control, as active pharmaceutical ingredients and excipients were released without identity testing or supplier qualification. Cleaning procedures for non-dedicated manufacturing equipment were not validated, leading to observed residues. Critical quality changes, such as cap specifications and product pH limits, were implemented without proper change control.These observations indicate a systemic failure to ensure product sterility and overall quality, posing potential risks to public health. The company is required to thoroughly investigate these issues, implement robust corrective and preventive actions, and ensure all manufacturing and quality control processes adhere to cGMP regulations to prevent recurrence.