# FDA 483 - Danmar Products, Inc. - November 04, 2024

Source: https://www.globalkeysolutions.net/records/483/danmar-products-inc/4d1d7bc4-ca6f-4623-b59f-17470de2a712

> FDA 483 for Danmar Products, Inc. on November 04, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Danmar Products, Inc.
- Inspection Date: 2024-11-04
- Product Type: device
- Office Name: Detroit District Office
- Summary: Danmar Products, Inc. in Ann Arbor, MI, received a Form FDA 483 with seven observations following an inspection. The findings highlight significant deficiencies in the firm's quality system, including inadequate documentation for process validation, corrective and preventive actions, equipment maintenance, complaint handling, supplier evaluations, incoming product acceptance, and personnel training. Several of these observations were repeats from a previous inspection, indicating persistent issues.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/felicia-e-armbrustmacher/83e0f3f7-2bfc-4250-8627-76685eee6b03)

Company: https://www.globalkeysolutions.net/companies/danmar-products-inc/e0efaa09-c225-4b86-8eb8-60e7903e3e89

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03