# FDA 483 - Tolmar, Inc. - January 31, 2023

Source: https://www.keypedia.com/records/483/tolmar-inc/a122c069-9f7a-44d2-b1cd-dd6e41e7d8de

> FDA 483 for Tolmar, Inc. on January 31, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tolmar, Inc.
- Inspection Date: 2023-01-31
- Product Type: drugs
- Office Name: Denver District Office
- Summary: Tolmar, Inc. in Fort Collins, CO, was cited for failing to thoroughly review unexplained discrepancies, specifically regarding repeated mold colony excursions in manufacturing rooms for their product Eligard. This is a serious repeat observation, indicating a persistent issue with the firm's investigation processes, including a lack of root cause analysis and corrective actions for environmental monitoring failures.

## Related Documents

- [483 - 2017-12-06](https://www.keypedia.com/records/483/tolmar-inc/6731193a-d03f-41f2-b46a-281d9a442ceb)
- [483 - 2020-01-28](https://www.keypedia.com/records/483/tolmar-inc/e2eefba5-3133-4634-8999-f90bf92e3072)

## Related Officers

- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Consumer Safety Officer](https://www.keypedia.com/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

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