FDA Inspection 1025424 — Hisamitsu Pharmaceutical Co., Inc.
The FDA completed an inspection of Hisamitsu Pharmaceutical Co., Inc. on September 15, 2017 in Tosu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tosu (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |