FDA Inspection 1110458 — American CryoStem Corporation

American CryoStem Corporation — FEI 3008307548

The FDA completed an inspection of American CryoStem Corporation on October 8, 2019 in Monmouth Junction, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). Product area: Biologics.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 8, 2019
Fiscal Year
2020
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Monmouth Junction, NJ (United States)