FDA Inspection 1106332 — Hisamitsu Pharmaceutical Co., Inc.
The FDA completed an inspection of Hisamitsu Pharmaceutical Co., Inc. on October 11, 2019 in Utsunomiya. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 11, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Utsunomiya (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4576 | 21 CFR 211.192 | No written record of investigation |