# FDA 483 - Harmac Medical Products, Inc. - December 12, 2019

Source: https://www.keypedia.com/records/483/harmac-medical-products-inc/ea9364e8-b7b3-45d4-aaaa-5e6b29879560

> FDA 483 for Harmac Medical Products, Inc. on December 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Harmac Medical Products, Inc.
- Inspection Date: 2019-12-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Harmac Medical Products, Inc., a medical device contract manufacturer in Buffalo, NY, identified one significant observation. The firm's procedures for corrective and preventive action were found to be inadequately established, with several CAPAs lacking proper verification or validation of effectiveness. This indicates a moderate compliance issue related to quality system controls.

## Related Documents

- [483 - 2022-02-11](https://www.keypedia.com/records/483/harmac-medical-products-inc/557e2b54-654a-449b-95e8-31f8f1af312e)

## 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