FDA Inspection 779402 — Charles River Laboratories Cell Solutions Inc
The FDA completed an inspection of Charles River Laboratories Cell Solutions Inc on April 19, 2012 in Memphis, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 19, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Memphis, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 121 | 21 CFR 606.121(c)(2) | Name, address, unique facility identifier |
| 123 | 21 CFR 606.121(c)(4)(i) | Expiration date |
| 128 | 21 CFR 606.121(c)(7) | Storage temperature in Celsius |
| 130 | 21 CFR 606.121(c)(9) | Infectious agent statement |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9219 | 21 CFR 606.100(b)(20) | Donor deferral |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |