FDA Inspection 697264 — Otsuka Pharmaceutical Development & Commercialization, Inc
The FDA completed an inspection of Otsuka Pharmaceutical Development & Commercialization, Inc on Oct 27, 2010 in Rockville, MD. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 27, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Rockville, MD (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |