FDA Inspection
Winchester Laboratories, LLCWinchester Laboratories, LLC – FDA Inspection, Jun 13, 2017
Record Details
This FDA Inspection record concerns Winchester Laboratories, LLC, with an inspection on June 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b4856889-3d83-43a3-97f3-55cc0264acf7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014220
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
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Other FDA inspections of Winchester Laboratories, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Winchester Laboratories, LLC
- FDA Inspection 774373 - 2012-03-12
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