FDA Inspection
Matech IncMatech Inc – FDA Inspection, May 19, 2011
Record Details
This FDA Inspection record concerns Matech Inc, with an inspection on May 19, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Matech Inc
- Inspection Date
- May 19, 2011
- Product Type
- Devices
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ID · df0fd2c0-9398-4cd4-9341-e00b7dff4cba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 725759
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Matech Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Matech Inc
- FDA Inspection 1009766 - 2017-04-18
- FDA Inspection 832479 - 2013-05-10
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