FDA Inspection 1055830 — Asanuma Corporation
The FDA completed an inspection of Asanuma Corporation on Jun 15, 2018 in Sagamihara. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 15, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sagamihara (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |