# FDA 483 - Gentell, Inc - August 25, 2015

Source: https://www.globalkeysolutions.net/records/483/gentell-inc/6ed11051-dda7-4bf2-bf13-23ea7c84fb74

> FDA 483 for Gentell, Inc on August 25, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gentell, Inc
- Inspection Date: 2015-08-25
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Gentell, Inc. in Bristol, PA, revealed significant deficiencies across its medical device quality system, particularly concerning the manufacturing and distribution of wound gauze and gel products. The firm failed to establish and maintain fundamental quality system elements, including management review, quality audits, CAPA, MDR, complaint handling, device records, process validation, environmental controls, equipment maintenance, and labeling. These widespread issues indicate a severe lack of control over critical aspects of medical device production.

## Related Documents

- [483 - 2019-12-12](https://www.globalkeysolutions.net/records/483/gentell-inc/2d84d826-b509-404d-a0fe-ddb416020614)

## Related Officers

- [Investigations](https://www.globalkeysolutions.net/people/edward-d-mcdonald/69224613-2b96-426a-99dd-e1cfe5ff1713)

Company: https://www.globalkeysolutions.net/companies/gentell-inc/96d27734-9ad8-46a1-9b0d-77fdcaaffb88

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