FDA 483 - Tolmar, Inc. - January 28, 2020

An FDA inspection of Tolmar, Inc. in Fort Collins, CO, from January 15-28, 2020, revealed a significant deficiency in procedures designed to prevent microbiological contamination of sterile drug products. Specifically, the firm's transport and loading procedures for aseptically filled, non-stoppered Eligard Syringe B syringes failed to ensure ISO 5 protection during transfer and storage, operating instead in an ISO 7 environment.