FDA Inspection 915063 — Sumitomo Pharma America, Inc.
The FDA completed an inspection of Sumitomo Pharma America, Inc. on Jan 23, 2015 in Marlborough, MA. 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 23, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Marlborough, MA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |