FDA Inspection 850881 — Continental Services Group, Inc.
The FDA completed an inspection of Continental Services Group, Inc. on September 27, 2013 in Ft Lauderdale, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Ft Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 225 | 21 CFR 640.4(f) | Closed system |
| 255 | 21 CFR 640.31 | Donor eligibility |
| 295 | 21 CFR 640.62 | Medical supervision |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9243 | 21 CFR 630.40(a) | Notification |
| 9261 | 21 CFR 610.40(a) | Test for HIV, HBV, HCV |
| 9286 | 21 CFR 640.16(b) | Sterile system |