FDA Inspection 1234860 — Sheffield Pharmaceuticals, LLC
The FDA completed an inspection of Sheffield Pharmaceuticals, LLC on Jun 18, 2025 in New London, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 18, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- New London, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |