FDA Inspection 776935 — Sheffield Pharmaceuticals, LLC
The FDA completed an inspection of Sheffield Pharmaceuticals, LLC on Apr 13, 2012 in New London, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 13, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New London, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 4390 | 21 CFR 211.180(c) | Photocopying of records not allowed |