FDA Inspection
Guy & O'Neill, IncGuy & O'Neill, Inc – FDA Inspection, Jan 26, 2011
Record Details
This FDA Inspection record concerns Guy & O'Neill, Inc, with an inspection on January 26, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Guy & O'Neill, Inc
- Inspection Date
- January 26, 2011
- Product Type
- Devices
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ID · d96ca924-10e0-4fbc-9b59-d8697ad2a037
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 703350
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
Showing 10 of 12 citations.
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Other FDA inspections of Guy & O'Neill, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 21, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 30, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Guy & O'Neill, Inc
- FDA Inspection 1022791 - 2017-07-25
- FDA Inspection 964874 - 2016-02-12
- FDA Inspection 871230 - 2014-03-21
- FDA Inspection 786218 - 2012-05-30
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