FDA Inspection 1152922 — Alora Pharmaceuticals LLC
The FDA completed an inspection of Alora Pharmaceuticals LLC on Sep 17, 2021 in Alpharetta, GA. 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
- Sep 17, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alpharetta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |