# FDA 483 - Graphic Controls Acquisition Corporation - February 23, 2021

Source: https://www.globalkeysolutions.net/records/483/graphic-controls-acquisition-corporation/6a6e71aa-3e83-4214-8da3-d770a4c04815

> FDA 483 for Graphic Controls Acquisition Corporation on February 23, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Graphic Controls Acquisition Corporation
- Inspection Date: 2021-02-23
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Graphic Controls Acquisition Corporation, a medical device manufacturer in Buffalo, NY, was cited for four observations during an FDA inspection. The inspection revealed significant deficiencies in supplier controls for AED defibrillator pads, failure to report serious adverse events via MDRs, inadequate management review procedures, and insufficient verification/validation within their CAPA system. These issues indicate a moderate level of non-compliance with quality system regulations, particularly concerning device safety and quality oversight.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/graphic-controls-acquisition-corporation/90ae2198-9a67-4d7e-87fb-0b9504b0ad29

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