FDA Inspection 746790 — Lead Chemical Co., Ltd.
The FDA completed an inspection of Lead Chemical Co., Ltd. on September 7, 2011 in Toyama. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 7, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Toyama (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |