FDA Inspection
The Metrix CompanyFDA Inspection 969394 - The Metrix Company - May 06, 2016
Record Details
This FDA Inspection record concerns The Metrix Company, with an inspection on May 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Metrix Company
- Inspection Date
- May 6, 2016
- Product Type
- Devices
View Company Profile
ID · a06abbdd-4658-4578-838e-6df1add924c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969394
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.200(b)Analyzing service report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The Metrix Company
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 22, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for The Metrix Company
- FDA Inspection 1088552 - 2019-04-25
- FDA Inspection 886826 - 2014-07-09
- FDA Inspection 662262 - 2010-04-22
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