FDA Inspection
Kentron Health Care IncKentron Health Care Inc – FDA Inspection, Oct 12, 2011
Record Details
This FDA Inspection record concerns Kentron Health Care Inc, with an inspection on October 12, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kentron Health Care Inc
- Inspection Date
- October 12, 2011
- Product Type
- Devices
View Company Profile
ID · 1fdc6f1a-4d23-4f4e-8fb1-c28b06f18e89
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 751028
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kentron Health Care Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 13, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Kentron Health Care Inc
- FDA Inspection 1118867 - 2020-02-05
- FDA Inspection 956497 - 2016-01-26
- FDA Inspection 787821 - 2012-06-13
- FDA Inspection 611888 - 2009-09-14
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