FDA Inspection 758639 — Reese Pharmaceutical Company
The FDA completed an inspection of Reese Pharmaceutical Company on January 11, 2012 in Cleveland, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 11, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |