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

Source: https://www.keypedia.com/records/483/kerber-usa-inc/5cf66d20-a2c1-454f-b21f-2dd41529321a

> FDA 483 for Kerber USA Inc. on November 02, 2022. Product: devices. 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: devices
- Office Name: New York District Office
- Summary: During an FDA inspection conducted from October 31 to November 2, 2022, medical device manufacturer Kerber USA Inc., located in Amherst, NY, received a Form FDA 483 outlining significant quality system deficiencies. The inspection revealed a systemic lack of established procedures critical for ensuring product quality and safety, as required by medical device regulations.

## Related Documents

- [483 - 2022-11-02](https://www.keypedia.com/records/483/kerber-usa-inc/4f9fb397-31f8-4450-97b8-c912ed9550ae)
- [483 - 2025-11-07](https://www.keypedia.com/records/483/kerber-usa-inc/2d6ea8b4-c2e1-456d-81a3-6741bd15fb1f)

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

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d