FDA Inspection 1253981 — JMS CO., LTD., Miyoshi Plant
The FDA completed an inspection of JMS CO., LTD., Miyoshi Plant on Oct 25, 2024 in Miyoshi. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 25, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Miyoshi (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |