FDA Inspection
Aaron Thomas Company IncAaron Thomas Company Inc – FDA Inspection, Sep 8, 2016
Record Details
This FDA Inspection record concerns Aaron Thomas Company Inc, with an inspection on September 8, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aaron Thomas Company Inc
- Inspection Date
- September 8, 2016
- Product Type
- Drugs
View Company Profile
ID · 5eccdca1-720e-46bc-94f0-b09e69d17c0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 984437
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Aaron Thomas Company Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 10, 2012 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| September 15, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aaron Thomas Company Inc
- FDA Inspection 820370 - 2013-02-28
- FDA Inspection 781580 - 2012-05-10
- FDA Inspection 681782 - 2010-09-15
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.