FDA Inspection
Heraeus Medical Components LLCHeraeus Medical Components LLC – FDA Inspection, Jul 2, 2013
Record Details
This FDA Inspection record concerns Heraeus Medical Components LLC, with an inspection on July 2, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 2, 2013
- Product Type
- Devices
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ID · f7bc1dee-25b2-455f-86aa-8b7b3bc64262
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 839975
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Heraeus Medical Components LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 25, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Heraeus Medical Components LLC
- FDA Inspection 1016481 - 2016-10-05
- FDA Inspection 680181 - 2010-08-25
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