# FDA 483 - Kerber USA Inc. - November 02, 2022

Source: https://www.keypedia.com/records/483/kerber-usa-inc/4f9fb397-31f8-4450-97b8-c912ed9550ae

> FDA 483 for Kerber USA Inc. on November 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kerber USA Inc.
- Inspection Date: 2022-11-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Kerber USA Inc., a medical device manufacturer in Amherst, NY, was cited with seven observations during an FDA inspection. The firm lacks fundamental quality system procedures across multiple critical areas, including design control, complaint handling, corrective and preventive actions, quality audits, device history records, supplier control, and nonconforming product control. This indicates a severe absence of a compliant quality management system for their medical device manufacturing operations.

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/kerber-usa-inc/299afbad-6c0d-4558-9c3d-2535d4d0c23a

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961