FDA Inspection 723394 — Sumitomo Pharma America, Inc.
The FDA completed an inspection of Sumitomo Pharma America, Inc. on Apr 20, 2011 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 20, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marlborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |