FDA Inspection 988463 — Shima Laboratories Co., Ltd.
The FDA completed an inspection of Shima Laboratories Co., Ltd. on Jul 28, 2016 in Itabashi. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 28, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Itabashi (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |