FDA Inspection
Accel IncAccel Inc – FDA Inspection, Nov 24, 2009
Record Details
This FDA Inspection record concerns Accel Inc, with an inspection on November 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Accel Inc
- Inspection Date
- November 24, 2009
- Product Type
- Drugs
View Company Profile
ID · 7e8ffc0c-bc60-400b-9d50-63bdb8941831
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 648845
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.80(a)Procedures To Be in Writing
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Accel Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2023 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| June 15, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 1, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 24, 2014 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| December 15, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Accel Inc
- FDA Inspection 1196765 - 2023-01-27
- FDA Inspection 1019852 - 2017-06-15
- FDA Inspection 1009628 - 2017-05-01
- FDA Inspection 876483 - 2014-04-24
- FDA Inspection 759169 - 2011-12-15
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