FDA Inspection 1107699 — Sato Pharmaceutical Co., Ltd.
The FDA completed an inspection of Sato Pharmaceutical Co., Ltd. on October 25, 2019 in Hachioji. 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
- October 25, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hachioji (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2017 | 21 CFR 211.188(b)(5) | In-Process and Laboratory Control Results |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |