# FDA 483 - Tolmar, Inc. - December 06, 2017

Source: https://www.keypedia.com/records/483/tolmar-inc/6731193a-d03f-41f2-b46a-281d9a442ceb

> FDA 483 for Tolmar, Inc. on December 06, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tolmar, Inc.
- Inspection Date: 2017-12-06
- Product Type: drugs
- Office Name: Denver District Office
- Summary: TOLMAR, Inc. in Fort Collins, CO, a drug manufacturer, received a Form 483 with two observations. The inspection revealed deficiencies in computer system controls, specifically regarding unique user accounts and data integrity, as well as inadequate supplier qualification practices for raw materials. These issues indicate potential risks to product quality and data reliability.

## Related Documents

- [483 - 2020-01-28](https://www.keypedia.com/records/483/tolmar-inc/e2eefba5-3133-4634-8999-f90bf92e3072)
- [483 - 2023-01-31](https://www.keypedia.com/records/483/tolmar-inc/a122c069-9f7a-44d2-b1cd-dd6e41e7d8de)

## Related Officers

- [Senior Consumer Safety Officer ](https://www.keypedia.com/people/marcus-f-yambot/a2266014-ae7e-4d64-aeba-a8cfb873f100)
- [https://www.fda.gov/media/120628/download](https://www.keypedia.com/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

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