Endymed Medical Inc.February 28, 2019

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

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Record Details

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.

Company: Endymed Medical Inc.
Inspection Date: February 28, 2019
Product Type: Other
Office: Division of Human and Animal Food Operations - East I
Person: Andrew J. Garufi

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