483
Heraeus Medical Components LLC FKA Evergreen MedicalFDA 483 - Heraeus Medical Components LLC FKA Evergreen Medical - April 26, 2019
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Record Details
An FDA inspection of Heraeus Medical Components LLC FKA Evergreen Medical, a medical device manufacturer in Saint Paul, MN, identified two significant issues. The firm failed to adequately validate a critical manufacturing process and did not properly document corrective and preventive action activities, including root cause and corrective actions for a customer complaint.
- Inspection Date
- April 26, 2019
- Product Type
- Device
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ID · a28e2d6c-5b41-4f07-8074-9ac33e1f5d2f