FDA Inspection 1018420 — Lead Chemical Co., Ltd.
The FDA completed an inspection of Lead Chemical Co., Ltd. on Jul 13, 2017 in Nakaniikawa-Gun. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 13, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nakaniikawa-Gun (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |