FDA Inspection 1001351 — Edge Pharma, LLC
The FDA completed an inspection of Edge Pharma, LLC on January 20, 2017 in Colchester, VT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Colchester, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |