FDA Inspection 877725 — Hisamitsu Pharmaceutical Co., Inc.
The FDA completed an inspection of Hisamitsu Pharmaceutical Co., Inc. on April 11, 2014 in Tosu. 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
- April 11, 2014
- Fiscal Year
- 2014
- 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 |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |