FDA Inspection 893817 — Edge Pharma, LLC
The FDA completed an inspection of Edge Pharma, LLC on Aug 20, 2014 in Colchester, VT. 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 20, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Colchester, VT (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 |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |