FDA Inspection 1120515 — Syntenza Pharmaceuticals, LLC
The FDA completed an inspection of Syntenza Pharmaceuticals, LLC on March 12, 2020 in Edina, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Edina, MN (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 10022 | 21 CFR 310.305(a) | Failure to develop written procedures |