Ideal Specialty Apothecary Inc., dba Ideal Pharmacy, Union, NJ. 483 Issued 08/31/2017

The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs and biologic products for human use and as required.

Following a recall initiated by Fresh Creative Foods, a division of Reser’s Fine Foods, Inc., Albertsons Companies has voluntarily recalled select store-made deli items, supplied by Fresh Creative Foods, due to possible Listeria monocytogenes contamination. The recall was initiated because these pro

CGMP/Active Pharmaceutical Ingredient (API)/Adulterated

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 12/19/2025
Short Title (70 char) F.H. Investments Inc dba Asteria Health. Birmingham, AL. 483 issued 12/19/2025
FEI Number 3038253438
Firm Name F.H. Investments Inc dba Asteria Health
Record Type 483
State AL
Es

Hofood99 Inc of Brooklyn, NY 11231 is recalling its 200g packages of Enoki Mushroom, because they may be contaminated with Listeria monocytogenes

This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.