FDA Inspection
Hampton Medical Devices, LLCHampton Medical Devices, LLC – FDA Inspection, Mar 15, 2012
Record Details
This FDA Inspection record concerns Hampton Medical Devices, LLC, with an inspection on March 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hampton Medical Devices, LLC
- Inspection Date
- March 15, 2012
- Product Type
- Devices
View Company Profile
ID · 32e78da7-c1ba-4c77-9615-73bb069cf1fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772394
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.160(b)Distribution records
- Medical Device Field Exam
- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.120(a)Remain legible
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Hampton Medical Devices, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 3, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 12, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hampton Medical Devices, LLC
- FDA Inspection 1157183 - 2021-11-08
- FDA Inspection 1073567 - 2018-12-03
- FDA Inspection 946075 - 2015-08-12
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