Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3013389992.
Observations3
Issue DateDecember 09, 2024
StatusNo Warning Letter
Establishment TypeReproductive Human Tissue
Related Inspections3
Establishment Details
Firm
GLOBAL FERTILITY & GENETICS
Location
New York, New York, United States
FEI Number
3013389992
Establishment Type
Reproductive Human Tissue
Product Type
Biologics
Issue Date
December 09, 2024
Country
United States
Inspection History, 2019 to 2024
NAI2
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.