FDA Inspection 974329 — W & C dba The Apothecary
The FDA completed an inspection of W & C dba The Apothecary on June 17, 2016 in Sartell, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 17, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sartell, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |