FDA Inspection 921522 — Sheffield Pharmaceuticals, LLC
The FDA completed an inspection of Sheffield Pharmaceuticals, LLC on March 19, 2015 in New London, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 19, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New London, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |