FDA Inspection 1081204 — Klockner Of North America

Klockner Of North America — FEI 3011395139

The FDA completed an inspection of Klockner Of North America on Feb 27, 2019 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 27, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Miami, FL (United States)

Citations

IDCFRDescription
1241721 CFR 1271.260(e)Periodic review of temperatures
1245721 CFR 1271.320(a)Procedures re complaints