FDA EIR - Tolmar, Inc. - January 28, 2020

A comprehensive FDA surveillance inspection of Tolmar, Inc., located in Fort Collins, CO, was conducted from January 15-28, 2020. The inspection focused on the company's Quality and Production systems for both sterile and non-sterile human drug products, including ELIGARD and Adapalene Benzoyl Peroxide Gel. The main violation identified, documented on Form FDA 483, concerned the lack of established procedures to prevent microbiological contamination of sterile drug products. Specifically, the transport and loading methods for aseptically filled, non-stoppered ELIGARD Syringe B syringes did not ensure the required ISO 5 protection, as mandated by the regulatory framework of 21 CFR 211.113(b). During the inspection, it was observed that the firm's practice of staging these syringes with a specific protective cover in an ISO 7 environment before final processing was deemed insufficient to maintain sterility. Tolmar's management, including VP of Quality Operations Mary S. Foster, acknowledged the observation. The company committed to re-evaluating their current practices and procedures to implement necessary corrections. A formal written response detailing their planned corrective actions was promised to the FDA within 15 business days of the inspection's conclusion.