FDA Inspection 984437 — Aaron Thomas Company Inc
The FDA completed an inspection of Aaron Thomas Company Inc on September 8, 2016 in Garden Grove, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 8, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Garden Grove, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |