FDA Inspection 1265193 — Senores Pharmaceuticals
The FDA completed an inspection of Senores Pharmaceuticals on Mar 28, 2025 in Buford, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 28, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Buford, GA (United States)
Additional details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |