FDA Inspection 615049 — Alkermes, Inc.
The FDA completed an inspection of Alkermes, Inc. on September 29, 2009 in Waltham, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Waltham, MA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6710 | 21 CFR 310.305(c)(2) | Submission of report follow-up |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |