FDA Inspection 803802 — Charles River Laboratories Edinburgh Ltd.
The FDA completed an inspection of Charles River Laboratories Edinburgh Ltd. on Sep 12, 2012 in Tranent. 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
- Sep 12, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tranent (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |