FDA Inspection
MP Biomedicals Diagnostics DivisionMP Biomedicals Diagnostics Division – FDA Inspection, Dec 13, 2017
Record Details
This FDA Inspection record concerns MP Biomedicals Diagnostics Division, with an inspection on December 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5ce56b9a-3b6c-47e1-be63-3f264d38cbfd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034831
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.184DHR content
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.86Acceptance status
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MP Biomedicals Diagnostics Division
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2026 | Not classified | Cincinnati District Office | Compliance: Medical Devices |
| December 15, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 22, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MP Biomedicals Diagnostics Division
- FDA Inspection 1310200 - 2026-03-31
- FDA Inspection 760696 - 2011-12-15
- FDA Inspection 657363 - 2010-04-22
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