FDA Inspection 1244549 — Kawasumi Laboratories (Thailand) Co. Ltd.
The FDA completed an inspection of Kawasumi Laboratories (Thailand) Co. Ltd. on Jul 25, 2024 in Chok Chai. 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 25, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chok Chai (Thailand)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3224 | 21 CFR 820.70(g)(2) | Periodic equipment inspection lack of or inadequate procedu |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |