# FDA 483 - Arnold Tuber Industries, LLC - February 20, 2025

Source: https://www.keypedia.com/records/483/arnold-tuber-industries-llc/c0b53304-364b-4a4e-b605-f169f29a5188

> FDA 483 for Arnold Tuber Industries, LLC on February 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arnold Tuber Industries, LLC
- Inspection Date: 2025-02-20
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Arnold Tuber Industries, LLC, a medical device manufacturer in Orchard Park, NY, revealed three significant observations. The firm was cited for inadequate validation of a manufacturing process, a lack of established procedures for design transfer, and an inadequately maintained device master record. These issues indicate deficiencies in the firm's quality system for medical device production.

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- [483 - 2022-03-14](https://www.keypedia.com/records/483/arnold-tuber-industries-llc/f55e7bd8-68d1-4d83-b073-a611b88c3353)

## Related Officers

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

Company: https://www.keypedia.com/companies/arnold-tuber-industries-llc/444b1656-4103-4d7b-851e-0f9db5ab6e40

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