# FDA 483 - Harmac Medical Products, Inc. - February 11, 2022

Source: https://www.keypedia.com/records/483/harmac-medical-products-inc/557e2b54-654a-449b-95e8-31f8f1af312e

> FDA 483 for Harmac Medical Products, Inc. on February 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Harmac Medical Products, Inc.
- Inspection Date: 2022-02-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Harmac Medical Products, Inc. in Buffalo, NY, a medical device contract manufacturer, identified two significant observations. The firm was cited for inadequate procedures regarding the verification and validation of corrective and preventive actions. Additionally, software used in production for dimensional analysis of components was found to be unvalidated for its intended use.

## Related Documents

- [483 - 2019-12-12](https://www.keypedia.com/records/483/harmac-medical-products-inc/ea9364e8-b7b3-45d4-aaaa-5e6b29879560)

## Related Officers

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

Company: https://www.keypedia.com/companies/harmac-medical-products-inc/412314bf-7ee2-4506-87f2-47c2569b6332

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