DDC Technologies, Inc.January 8, 2020

FDA 483 - DDC Technologies, Inc. - January 08, 2020

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Record Details

DDC Technologies Inc. in Oceanside, NY, received a Form FDA 483 with three repeat observations during an inspection from January 6-8, 2020. The firm was cited for inadequate procedures regarding design changes, environmental controls in the production area, and management reviews. These findings indicate significant deficiencies in the company's quality system for manufacturing laser devices.

Company: DDC Technologies, Inc.
Inspection Date: January 8, 2020
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Ronald Ifraimov (investigator)

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ID · 5a2de023-fd36-41ca-813f-dc9191574e36