FDA Inspection 770008 — Hisamitsu Pharmaceutical Co., Inc.
The FDA completed an inspection of Hisamitsu Pharmaceutical Co., Inc. on February 17, 2012 in Tosu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tosu (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |