FDA Inspection 874760 — Astellas Pharma Inc.
The FDA completed an inspection of Astellas Pharma Inc. on Apr 11, 2014 in Takaoka. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 11, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Takaoka (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |