# FDA WARNING_LETTER - Gentell - August 25, 2015

Source: https://www.globalkeysolutions.net/records/warning_letter/gentell/cf6884a0-c454-4a15-903b-91ded7f8910c

> FDA WARNING_LETTER for Gentell on August 25, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Gentell
- Inspection Date: 2015-08-25
- Product Type: Devices
- Office Name: Philadelphia District Office
- Summary: On October 5, 2015, the FDA issued a Warning Letter to Gentell Inc. following an inspection from July 29 to August 25, 2015. The inspection revealed that Gentell Inc., a manufacturer of wound dressings and gauzes, was not in conformance with current Good Manufacturing Practice (cGMP) requirements for medical devices, rendering their devices adulterated under 21 U.S.C. § 351(h).

Key violations included:
1. **Failure to adequately establish and maintain an organizational structure** (21 CFR 820.20), lacking appropriate personnel with authority over quality assessment and a defined quality system.
2. **Failure to establish procedures for corrective and preventive action (CAPA)** (21 CFR 820.100(a)), with no established system to identify, investigate, and correct quality problems.
3. **Failure to establish a formally designated unit and procedures for receiving, reviewing, and evaluating complaints** (21 CFR 820.198(a)).
4. **Failure to validate processes** (21 CFR 820.75(a)), including manufacturing processes for tubes, gamma sterilization for dressings, and package sealing.
5. **Failure to maintain a device master record (DMR)** (21 CFR 820.181) with approved specifications.
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## Related Documents

- [483 - 2019-12-16](https://www.globalkeysolutions.net/records/483/gentell/67927409-bc63-46ee-9749-c1b8f06f6dc9)

## Related Officers

- [Senior Science Advisor](https://www.globalkeysolutions.net/people/anne-e-johnson/e16f97ea-b090-4107-b7dd-b02233b68919)

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