FDA Inspection 608872 — Sumitomo Pharma America, Inc.
The FDA completed an inspection of Sumitomo Pharma America, Inc. on Sep 1, 2009 in Marlborough, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 1, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Marlborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |