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

Source: https://www.keypedia.com/records/483/tolmar-inc/e2eefba5-3133-4634-8999-f90bf92e3072

> FDA 483 for Tolmar, Inc. on January 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tolmar, Inc.
- Inspection Date: 2020-01-28
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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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## Related Officers

- [Pharmaceutical Program Expert](https://www.keypedia.com/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)

Company: https://www.keypedia.com/companies/tolmar-inc/0f03b95a-a7e1-4a49-a5f7-5f6842df7d92

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face