# FDA 483 - ARTAFLEX BUFFALO INC - July 09, 2026

Source: https://www.keypedia.com/records/483/artaflex-buffalo-inc/a9290441-99e2-4aad-8f84-5c4b979a1381

> FDA 483 for ARTAFLEX BUFFALO INC on July 09, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARTAFLEX BUFFALO INC
- Inspection Date: 2026-07-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: ARTAFLEX BUFFALO INC, a medical device contract manufacturer in Buffalo, NY, received three observations during an FDA inspection. The observations highlight significant deficiencies in the firm's quality system, specifically regarding inadequate documentation and implementation of production controls for labeling and packaging, procedures for nonconforming product, and risk management processes. These issues indicate a lack of robust controls over critical manufacturing and quality assurance activities.

## Related Officers

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

Company: https://www.keypedia.com/companies/artaflex-buffalo-inc/13952c5c-011e-4cd3-b92f-378e067f3439

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