1248991
Annovex Pharma, Inc. — FEI 3020928491
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 6, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lorton, VA (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 |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21422 | FDCA 503B(b)(2)(A) | Outsourcing facility, compounded drug report follow up |
| 22787 | FDCA 503B(a)(10)(A) | Drug product labels, fails to include |