Triad Rx, Inc – FDA 483, Dec 8, 2022

An FDA inspection of Triad Rx, Inc., a non-sterile drug producer, was conducted from December 5 to December 8, 2022, resulting in the issuance of an FDA Form 483. The primary observation identified a critical deficiency in the company's manufacturing processes: the production of hazardous drugs without adequate cleaning protocols for work surfaces and utensils to prevent cross-contamination. Specifically, inspectors noted the absence of a deactivating agent used for cleaning between the production of different hazardous drug products, such as various BI-EST 50:50 creams. This practice raises concerns about potential adulteration and patient safety risks. These findings were reported under Section 704(b) of the Federal Food, Drug and Cosmetic Act, which addresses conditions indicating drugs may be prepared or held under insanitary conditions. Triad Rx, Inc. is now expected to promptly address these observations by developing and implementing comprehensive corrective actions to ensure compliance with regulatory standards for drug manufacturing.