FDA Inspection 1048077 — Sarepta Therapeutics, Inc.
The FDA completed an inspection of Sarepta Therapeutics, Inc. on April 12, 2018 in Cambridge, MA. 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
- April 12, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Cambridge, MA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 18024 | 21 CFR 314.80(c)(2)(ii)(B) | Periodic safety report missing ICSR |