FDA Inspection 1110236 — Collaborative Laboratory Services, LLC- Saint Francis Campus

Collaborative Laboratory Services, LLC- Saint Francis Campus — FEI 1270168

The FDA completed an inspection of Collaborative Laboratory Services, LLC- Saint Francis Campus on November 18, 2019 in Hartford, CT. 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: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 18, 2019
Fiscal Year
2020
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Hartford, CT (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
922521 CFR 606.171Biological product deviation report