FDA Inspection
Heraeus Medical Components LLC FKA Evergreen MedicalHeraeus Medical Components LLC FKA Evergreen Medical – FDA Inspection, Apr 26, 2019
Record Details
This FDA Inspection record concerns Heraeus Medical Components LLC FKA Evergreen Medical, with an inspection on April 26, 2019, issued by the Minneapolis District Office, covering medical devices & rad health.
- Inspection Date
- April 26, 2019
- Product Type
- Medical Devices & Rad Health
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ID · 49d29d3c-1c88-4f42-bf6f-01f5174f6b0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087847
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Heraeus Medical Components LLC FKA Evergreen Medical
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Heraeus Medical Components LLC FKA Evergreen Medical
- FDA Inspection 808400 - 2012-11-06
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