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483
•Freudenberg Medical, LLC•September 19, 2016

Freudenberg Medical, LLC – FDA 483, Sep 19, 2016

Record Details

Freudenberg Medical, LLC, a medical device contract manufacturer in Baldwin Park, CA, was inspected by the FDA. The inspection revealed a significant quality system deficiency related to the lack of validation for a critical manufacturing process for a medical device, which could impact product quality and safety.

Company
Freudenberg Medical, LLC
Inspection date
September 19, 2016
Product type
device
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Janet Pulver (Investigator)
View Company Profile

ID · 0a2e6f55-bfcd-46ce-b3e3-034cb63c5336

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