FDA Inspection 966461 — JMS CO.,Ltd. Chiyoda Plant
The FDA completed an inspection of JMS CO.,Ltd. Chiyoda Plant on March 25, 2016 in Kita-Hiroshima-Cho. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 25, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kita-Hiroshima-Cho (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |