# FDA 483 - Endymed Medical Inc. - February 28, 2019

Source: https://www.globalkeysolutions.net/records/483/endymed-medical-inc/ff0372f6-e780-41b7-946b-9b01401a3bda

> FDA 483 for Endymed Medical Inc. on February 28, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Endymed Medical Inc.
- Inspection Date: 2019-02-28
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Endomed Medical Inc. in East Freehold, NJ, was inspected by the FDA on February 28, 2019. The inspection revealed a significant issue regarding the firm's complaint handling system. Specifically, the company failed to establish written procedures for receiving, reviewing, and evaluating complaints, indicating a fundamental gap in its quality system.

## Related Officers

- [Andrew J. Garufi](https://www.globalkeysolutions.net/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.globalkeysolutions.net/companies/endymed-medical-inc/61b65b55-e8aa-4a78-8393-354dd189241f

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