FDA Inspection
Protek Medical Products IncProtek Medical Products Inc – FDA Inspection, Aug 8, 2019
Record Details
This FDA Inspection record concerns Protek Medical Products Inc, with an inspection on August 8, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 47f30340-0937-42ef-a00d-5db9c3f69cd0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1099061
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Protek Medical Products Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 6, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 21, 2014 | VAI | 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 989313 - 2016-10-06
- FDA Inspection 863555 - 2014-01-21
- FDA Inspection 598379 - 2009-07-21
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