FDA Inspection 800238 — Seikagaku Corporation (Takahagi Plant)
The FDA completed an inspection of Seikagaku Corporation (Takahagi Plant) on Sep 6, 2012 in Takahagi. 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
- Sep 6, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Project Evaluation: Devices
- Location
- Takahagi (Japan)
Additional details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |