FDA Inspection
Guy & O'Neill, IncGuy & O'Neill, Inc – FDA Inspection, Feb 12, 2016
Record Details
This FDA Inspection record concerns Guy & O'Neill, Inc, with an inspection on February 12, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Guy & O'Neill, Inc
- Inspection Date
- February 12, 2016
- Product Type
- Drugs
View Company Profile
ID · 4ad8a666-670e-474a-83d9-3b13c3bc0f92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 964874
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.165(a)Testing and release for distribution
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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 |
| 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 |
| January 26, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Guy & O'Neill, Inc
- FDA Inspection 1022791 - 2017-07-25
- FDA Inspection 871230 - 2014-03-21
- FDA Inspection 786218 - 2012-05-30
- FDA Inspection 703350 - 2011-01-26
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