Moldworks Worldwide LLCFebruary 13, 2020

FDA 483 - Moldworks Worldwide LLC - February 13, 2020

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Record Details

An FDA inspection of Moldworks Worldwide LLC in Linden, NJ, identified a single observation related to inadequate documentation of acceptance activities. The firm failed to document measurements of finished devices to ensure conformance with Device Master Record specifications. This indicates a deficiency in their quality system for device manufacturing.

Company: Moldworks Worldwide LLC
Inspection Date: February 13, 2020
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Andrew J. Garufi

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ID · 0acfefcd-7895-4a2f-86c6-7696592370ab