# FDA 483 - Wound Healing Technologies - March 02, 2022

Source: https://www.globalkeysolutions.net/records/483/wound-healing-technologies/7a741f40-b6a1-4d6a-b2e5-e2bf66be326b

> FDA 483 for Wound Healing Technologies on March 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wound Healing Technologies
- Inspection Date: 2022-03-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Wound Healing Technologies, a medical device distributor in Brooklyn, NY, received a Form 483 with four observations during an FDA inspection. The firm was cited for significant deficiencies in its quality system, including the absence of established procedures for servicing activities, incoming product acceptance, complaint handling, and Medical Device Reporting (MDR). These findings indicate a lack of fundamental controls necessary for ensuring device quality and post-market surveillance.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.globalkeysolutions.net/companies/wound-healing-technologies/3e4bd372-bc7e-4cc5-bc6d-d1d4da48a741

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961