FDA Inspection
Protek Medical Products IncProtek Medical Products Inc – FDA Inspection, Jan 21, 2014
Record Details
This FDA Inspection record concerns Protek Medical Products Inc, with an inspection on January 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Protek Medical Products Inc
- Inspection Date
- January 21, 2014
- Product Type
- Devices
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ID · cc53b35a-3b94-47eb-a804-446c9bde524f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863555
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.70(d)Implementing Personnel Procedures, Health, Cleanliness.
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Other FDA inspections of Protek Medical Products Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 6, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 21, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Protek Medical Products Inc
- FDA Inspection 1099061 - 2019-08-08
- FDA Inspection 989313 - 2016-10-06
- FDA Inspection 598379 - 2009-07-21
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