FDA Inspection 754803 — Otsuka Pharmaceutical Co., Ltd.
The FDA completed an inspection of Otsuka Pharmaceutical Co., Ltd. on Oct 21, 2011 in Itano-Gun. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Itano-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |