# FDA 483 - Gentell - December 16, 2019

Source: https://www.globalkeysolutions.net/records/483/gentell/67927409-bc63-46ee-9749-c1b8f06f6dc9

> FDA 483 for Gentell on December 16, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gentell
- Inspection Date: 2019-12-16
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: Gentell, a medical device firm in Bristol, PA, was cited for failing to ensure the appropriate design, construction, placement, and installation of manufacturing equipment. Specifically, their labeling system for wound cleanser was not qualified for its intended use, including maintenance and calibration requirements.

## Related Documents

- [WARNING_LETTER - 2015-08-25](https://www.globalkeysolutions.net/records/warning_letter/gentell/cf6884a0-c454-4a15-903b-91ded7f8910c)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/gentell/f1be9ee8-d5cd-48bb-b91d-ae8204bced09

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