# FDA 483 - Fieldtex Products, Inc. - October 04, 2022

Source: https://www.globalkeysolutions.net/records/483/fieldtex-products-inc/675d37c4-7ae0-4ff3-8355-a5f5062e6da5

> FDA 483 for Fieldtex Products, Inc. on October 04, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fieldtex Products, Inc.
- Inspection Date: 2022-10-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Fieldtex Products, Inc., a medical device manufacturer in Rochester, NY, was cited with eight observations during an FDA inspection from September 30 to October 4, 2022. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for supplier control, nonconforming product, CAPA, process control, complaint handling, and a lack of essential documentation. These issues indicate a broad failure to establish and maintain a compliant quality system for medical device manufacturing.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/fieldtex-products-inc/f349f0f0-a476-4ea9-aa18-906e52afe303

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