# FDA 483 - TOLMAR, Inc. - June 17, 2022

Source: https://www.globalkeysolutions.net/records/483/tolmar-inc/0fb47cf9-cde2-4e33-898b-48e430018f52

> FDA 483 for TOLMAR, Inc. on June 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TOLMAR, Inc.
- Inspection Date: 2022-06-17
- Product Type: drugs
- Office Name: Denver District Office
- Summary: TOLMAR, Inc. in Windsor, CO, was inspected and cited for four observations related to manufacturing controls for its Paliperidone Palmitate Extended-Release Injectable Suspension. Deficiencies included inadequate equipment design, lack of material qualification for API samples, unestablished test method sensitivity, and insufficient cleaning procedures. These issues indicate a lack of control over aseptic processing, material quality, and laboratory testing, posing potential risks to product sterility and quality.

## Related Documents

- [483 - 2020-02-24](https://www.globalkeysolutions.net/records/483/tolmar-inc/0858b7a9-6708-46dd-89da-34a43daf261c)

## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/michael-t-cyrus/30e497e1-2c17-4dd7-9a5b-251771cf4266)
- [Christopher M. Jenner](https://www.globalkeysolutions.net/people/christopher-m-jenner/d2fbd516-71aa-4263-8ffb-57b8149d6b64)
- [investigator](https://www.globalkeysolutions.net/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)

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