CGMP/OTC/Adulterated/Misbranded
Similar Posts
Olympia Pharmaceuticals. Orlando, FL. 483 issued 08/08/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 08/08/2025
Short Title (70 char) Olympia Pharmaceuticals. Orlando, FL. 483 issued 08/08/2025
FEI Number 3009724085
Firm Name Olympia Pharmaceuticals
Record Type 483
State FL
Establishment Type Outsourcing FaciliAgebox Inc. – 718252 – 12/19/2025
Unapproved New Drug/MisbrandedAlvotech HF – 07/04/2025
Alvotech HF – 07/04/2025. Country: Iceland. Record Type: 483Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System and Cheetah Delivery Tool After FDA Warning Letter About Internal Processes and Distal Tip Characteristics
The Hippo 072 Aspiration System is used to remove stroke-causing clots but there may be issues with the distal tip during clot removal.Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration Systems
This communication is part of the Communications Pilot to Enhance the Medical Device Recall ProgramDigital Health Technologies (DHTs) for Drug Development
Digital Health Technologies (DHTs) for Drug Development