483
Moldex-Metric, Inc.FDA 483 - Moldex-Metric, Inc. - March 05, 2026
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Record Details
An FDA inspection of Moldex-Metric, Inc. in Culver City, CA, a medical device manufacturer, identified two observations related to quality system deficiencies. The firm failed to maintain records of risk management activities for its N95 Healthcare and Surgical Mask Family of Product and did not maintain a design and development file for this medical device family.
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ID · ae0ab39e-60ed-4345-804f-eac4d4724c54