FDA Inspection 1078933 — CGG Medical Inc.

CGG Medical Inc. — FEI 3014250051

The FDA completed an inspection of CGG Medical Inc. on February 11, 2019 in Tallahassee, FL. 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
February 11, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Tallahassee, FL (United States)

Citations

IDCFRDescription
1233621 CFR 1271.180(a)Procedures to meet core CTGP
1245721 CFR 1271.320(a)Procedures re complaints