FDA Inspection 626544 — Collaborative Laboratory Services, LLC- Saint Francis Campus
The FDA completed an inspection of Collaborative Laboratory Services, LLC- Saint Francis Campus on October 30, 2009 in Hartford, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 30, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hartford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 157 | 21 CFR 606.160(d) | Retention period |
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |