FDA Inspection
Stratec Medizintechnik GmbhStratec Medizintechnik Gmbh – FDA Inspection, Sep 7, 2011
Record Details
This FDA Inspection record concerns Stratec Medizintechnik Gmbh, with an inspection on September 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Stratec Medizintechnik Gmbh
- Inspection Date
- September 7, 2011
- Product Type
- Devices
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ID · a89e3816-a5bc-4548-bbdf-f1328c167a27
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 742745
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Stratec Medizintechnik Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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