FDA Inspection 1039835 — Poly Pharmaceuticals, Inc
The FDA completed an inspection of Poly Pharmaceuticals, Inc on Jan 24, 2018 in Owens Cross Roads, AL. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 24, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Owens Cross Roads, AL (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |