# FDA 483 - TOLMAR, Inc. - February 24, 2020

Source: https://www.globalkeysolutions.net/records/483/tolmar-inc/0858b7a9-6708-46dd-89da-34a43daf261c

> FDA 483 for TOLMAR, Inc. on February 24, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TOLMAR, Inc.
- Inspection Date: 2020-02-24
- Product Type: drugs
- Office Name: Denver District Office
- Summary: TOLMAR, Inc. in Windsor, CO, a sterile parenteral and topical drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into discrepancies, a lack of established procedures to prevent microbiological contamination in sterile drug production, and insufficient environmental and equipment controls. These issues indicate a systemic failure in maintaining a state of control over critical manufacturing processes and quality systems.

## Related Documents

- [483 - 2022-06-17](https://www.globalkeysolutions.net/records/483/tolmar-inc/0fb47cf9-cde2-4e33-898b-48e430018f52)

## Related Officers

- [Pharmaceutical Program Expert](https://www.globalkeysolutions.net/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)
- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

Company: https://www.globalkeysolutions.net/companies/tolmar-inc/a73dea00-baea-4f0e-8234-c0becc61322e

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