NDA and BLA Calendar Year Approvals

The Food and Drug Administration is advising consumers not to purchase or use PAIN FLEX, a product promoted and sold for joint pain on various websites, including Amazon.com and possibly in some retail stores.

CGMP/Finished Pharmaceuticals/Adulterated

Aurobindo Pharma Ltd. Unit-XII – 09/5/2025. Country: India. Record Type: 483

Drug Trials Snapshots: LYNKUET

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/23/2025
Short Title (70 char) Park Avenue Compounding. Saint Louis, MO. 483 issued 09/23/2025
FEI Number 1972829
Firm Name Park Avenue Compounding
Record Type 483
State MO
Establishment Type Outsourcing Facil

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.