# FDA 483 - Little Rapids Corporation - August 23, 2024

Source: https://www.keypedia.com/records/483/little-rapids-corporation/3924c58d-f154-45d2-a1bb-a765d414a1de

> FDA 483 for Little Rapids Corporation on August 23, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Little Rapids Corporation
- Inspection Date: 2024-08-23
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Little Rapids Corporation in Green Bay, WI, revealed significant deficiencies in their quality system, many of which were repeat observations from a previous inspection. Key issues included inadequate documentation for corrective actions, lack of established procedures for incoming product acceptance and supplier control, and failure to submit a Medical Device Report (MDR) for a patient skin reaction. The findings indicate a persistent lack of adherence to quality system requirements.

## Related Officers

- [Ulysses D. Singleton](https://www.keypedia.com/people/ulysses-d-singleton/e62f9da3-2c82-4ad7-910d-2da18144c789)

Company: https://www.keypedia.com/companies/little-rapids-corporation/a8c0bd6c-6cb8-44ca-87a5-089482b267e2

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d