FDA 483 - Profounda Inc - August 30, 2024

The FDA conducted an inspection of "Distributer," an OTC drug manufacturer and own-label distributor, from August 26 to August 30, 2024. The inspection revealed significant deviations from Current Good Manufacturing Practice (cGMP) regulations, as detailed in an FDA 483 document.Key findings included a lack of defined responsibilities and adherence within the Quality Control Unit. Deficiencies encompassed inadequate management of quality events like investigations, deviations, and corrective actions, absence of impact assessments for changes, and failure to implement an annual program review. The firm also failed to properly control out-of-service equipment, ensure adequate complaint handling and field alert procedures, and establish a robust supplier qualification program, with cleaning and maintenance logbooks not reviewed promptly.A critical repeated observation highlighted inadequate procedures for handling drug product complaints, with the firm incorrectly referencing medical device regulations (21 CFR 803) instead of drug product requirements (21 CFR 211). Furthermore, the company lacked processes for adverse event and field alert reporting.Laboratory controls were found lacking, specifically concerning the scientific soundness and suitability of microbiology testing methods for drug products like Rhinase D Nasal Gel. Lastly, cleaning processes for shared equipment and utensils used in the production of Rhinase D Nasal Gel were not validated, posing a risk of product contamination.To achieve compliance, Distributer must promptly address these observations by implementing comprehensive corrective and preventive actions across its quality, laboratory, and production systems, ensuring adherence to cGMP requirements.