483
Tolmar, Inc.Tolmar, Inc. – FDA 483, Jan 28, 2020
Record Details
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.
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ID · e2eefba5-3133-4634-8999-f90bf92e3072
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