GDUFA Type II API DMF Payment Receipts Report

This training represents regulatory intelligence that sets global standards for clinical research. The content reflects current FDA thinking, emerging guidance, and real-world regulatory experience, providing participants with the most reliable and up-to-date information available.

ENDICO POTATOES of MOUNT VERNON NY is recalling Endico brand PEAS AND CARROTS AND MIXED VEGETABLES, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/20/2025
Short Title (70 char) BlendHouse Allerton LLC. Allerton, IA. EIR issued 02/20/2025
FEI Number 1921383
Firm Name BlendHouse Allerton LLC
Record Type EIR
State IA
Establishment Type Manufacturer

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples.

Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program is intended to increase awareness for FDA guidance documents to support the efficient application of the documents’ recommendations.

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 01/19/2024
Short Title (70 char) BlendHouse LLC. Reading, PA. EIR issued 01/19/2024
FEI Number 3015728839
Firm Name BlendHouse LLC
Record Type EIR
State PA
Establishment Type Manufacturer