Smilax Laboratories Limited – FDA 483, Sep 15, 2023

During an FDA inspection conducted from September 11-15, 2023, the firm ORAPHARM International received a Form FDA 483 detailing significant observations regarding its quality system. The primary issue identified was the company's failure to adhere to its own standard operating procedure (SOP No. CQA008/03) for investigation and corrective and preventive action management. This SOP specifically requires extending investigations to other batches and products that could be potentially affected by an identified issue. The inspection revealed two specific instances of non-compliance. First, the firm did not adequately extend the investigation into a complaint (Document No. MC-V-22-005) received on September 5, 2023, concerning the presence of a dead insect and black foreign particles observed within product material. Second, a similar failure occurred with complaint Document No. MC-V-22-003, which reported foreign particles in another material, where the investigation was also not appropriately expanded to determine potential broader impact. These observations highlight a systemic breakdown in ORAPHARM International's quality control processes, specifically its approach to root cause analysis and impact assessment following product complaints. The issuance of the FDA 483 signifies that the FDA representatives observed conditions that may constitute violations of the Federal Food, Drug, and Cosmetic Act and related regulations. ORAPHARM International is expected to promptly address these observations by implementing comprehensive corrective and preventive actions and submitting a written response to the FDA.