FDA Inspection
MP Biomedicals Diagnostics DivisionMP Biomedicals Diagnostics Division – FDA Inspection, Mar 31, 2026
Record Details
This FDA Inspection record concerns MP Biomedicals Diagnostics Division, with an inspection on March 31, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
- Inspection Date
- March 31, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 2cc0bce1-369e-447c-a594-80fd59ea225f
Inspection Facts
- Inspection number
- 1310200
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
- ISO 13485:2016 Clause 7.6(a)Measuring equipment not adequately calibrated or verified
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Other FDA inspections of MP Biomedicals Diagnostics Division
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2017 | VAI | Center for Devices and Radiological Health | Compliance: 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 1034831 - 2017-12-13
- FDA Inspection 760696 - 2011-12-15
- FDA Inspection 657363 - 2010-04-22
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