# FDA 483 - Arnold Tuber Industries, LLC - March 14, 2022

Source: https://www.keypedia.com/records/483/arnold-tuber-industries-llc/f55e7bd8-68d1-4d83-b073-a611b88c3353

> FDA 483 for Arnold Tuber Industries, LLC on March 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arnold Tuber Industries, LLC
- Inspection Date: 2022-03-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Arnold Tuber Industries, LLC, a medical device manufacturer in Orchard Park, NY, identified two significant observations. The firm was cited for inadequate procedures for corrective and preventive actions, specifically regarding verification and validation of their effectiveness. Additionally, the inspection found that a critical process for standard syringe caps lacked adequate validation, with issues in statistical rationale for sample and batch sizes.

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## 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/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961