Information related to FDA’s preparation for the seventh reauthorization of PDUFA.
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Middlefield Original Cheese Co-Op Recalls Organic Gouda, Colored Cheddar, Mozzarella/Provolone, Pepper Jack, Swiss, Dilly Pickle Cheese and Monterey Jack Due to Possible Listeria Monocytogenes Contamination
Middlefield, OH 9/5/25 – The Middlefield Original Cheese Co-Op facility in Middlefield, OH is recalling one lot of Sunrise Creamery Dilly Pickle Monterey Jack Cheese with Dill Pickles in 6 oz. and 1.25 lb. packages, one lot of Organic Gouda Cheese in 8 oz. packages, and specific lots of Mozzarella/PXXX Zone 40K contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use XXX Zone 40K, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.MedisourceRx. Los Alamitos, CA. 483 issued 06/10/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/10/2025
Short Title (70 char) MedisourceRx. Los Alamitos, CA. 483 issued 06/10/2025
FEI Number 3013316698
Firm Name MedisourceRx
Record Type 483
State CANorthern VA Compounders PLLC, dba Akina Pharmacy – 671700 – 04/12/2024
Compounding Pharmacy/Adulterated Drug ProductsGDUFA Paid Facilities List
This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list:CSL Behring – 716297 – 09/09/2025
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)