FDA Inspection 942540 — Lead Chemical Co., Ltd.
The FDA completed an inspection of Lead Chemical Co., Ltd. on August 28, 2015 in Toyama. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 28, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Toyama (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |