FDA Inspection 909056 — Charles River Laboratories Edinburgh Ltd.
The FDA completed an inspection of Charles River Laboratories Edinburgh Ltd. on December 17, 2014 in Tranent. 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
- December 17, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tranent (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |