# FDA 483 - Femcap Inc - August 08, 2025

Source: https://www.keypedia.com/records/483/femcap-inc/4b5c8cf7-c728-4855-a02d-a8780721aa2e

> FDA 483 for Femcap Inc on August 08, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Femcap Inc
- Inspection Date: 2025-08-08
- Product Type: device
- Office Name: Detroit District Office
- Summary: Femcap, Inc. in Warren, MI, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection found that the firm lacked adequate procedures for supplier control, incoming product acceptance, and the management of nonconforming products. These issues indicate a serious breakdown in ensuring product quality and compliance.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/femcap-inc/14e00c1f-7264-461e-a8ce-c517067305ec

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