# FDA 483 - Dymax Corp - July 30, 2021

Source: https://www.globalkeysolutions.net/records/483/dymax-corp/9ad5066e-abe7-462f-8bff-ffa10aaeaed4

> FDA 483 for Dymax Corp on July 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dymax Corp
- Inspection Date: 2021-07-30
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Dymax Corp, a medical device manufacturer in Zelienople, PA, identified a significant issue with the control of non-conforming products. Specifically, the firm failed to adequately control Breast Biopsy System medical devices containing incorrectly wired cooling fans, resulting in the release and distribution of faulty units. This indicates a lapse in quality system controls for product specifications and release.

## Related Officers

- [Katelyn A. Staub-Zamperini](https://www.globalkeysolutions.net/people/katelyn-a-staub-zamperini/bb7f95a4-53c1-473c-856e-517312bdba30)

Company: https://www.globalkeysolutions.net/companies/dymax-corp/1fec86c2-a9c4-4734-8b06-2f257d983936

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8