# FDA 483 - Hoosier, Inc - August 21, 2025

Source: https://www.keypedia.com/records/483/hoosier-inc/2759f594-018c-43ae-a57b-9d00f484dd63

> FDA 483 for Hoosier, Inc on August 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hoosier, Inc
- Inspection Date: 2025-08-21
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Hoosier, Inc., a contract manufacturer of surgical implantable devices in Corona, CA, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily concern inadequate validation of equipment, insufficient supplier and customer agreements, and deficiencies in CAPA, complaint handling, and incoming material acceptance procedures. These issues indicate a lack of robust control over critical manufacturing and quality processes.

## Related Officers

- [Linda Galindo](https://www.keypedia.com/people/linda-galindo/6bc29df6-192b-4d89-92ae-20cc1660d9ad)

Company: https://www.keypedia.com/companies/hoosier-inc/0f6d66b1-20e6-402c-842f-a8a49ec4b80b

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b