Early Alert: Glucose Monitor Sensor Issue from Abbott Diabetes Care

KEYNOTE SPEAKER – Janet Woodcock MD, Acting Commissioner of FDA

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) FarmaKeio Outsourcing LLC. Southlake, TX. 483 issued 09/05/2025
FEI Number 3014982757
Firm Name FarmaKeio Outsourcing LLC
Record Type 483
State TX
Establishment Type Outsourcing

This is to update and consolidate the extended use date information posted previously to assist with drug shortage (6/15/17 to present).

Therefore, in order to ensure that batches of imported heparin continue to meet regulatory standards, FDA is requiring that all lots of Heparin Sodium be required to be in compliance with latest USP specifications.

CGMP/Finished Pharmaceuticals/Adulterated

In accordance with section 505A(e)(1) of the Act, as amended by FDAAA (Pub. L. No. 110-85), the following list identifies those approved drugs for which a pediatric exclusivity determination was made, on or after September 27, 2007.