FDA Inspection 845707 — ImprimisRx NJ LLC
The FDA completed an inspection of ImprimisRx NJ LLC on Aug 19, 2013 in Ledgewood, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 19, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ledgewood, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |