CDER Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality (CDER Quality Standards Program)

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/25/2025
Short Title (70 char) IntegraDose Compounding Services LLC. Minneapolis, MN. 483 issued 07/25/2025
FEI Number 3014483112
Firm Name IntegraDose Compounding Services LLC
Record Type 483
State MN
Establi

Southwind Foods, LLC of Carson, California is voluntarily recalling a limited quantity of Frozen Shrimp, due to possible radionuclide (Cesium-137) contamination. Cs-137 is a man-made radioisotope of cesium. Traces of Cs-137 are widespread and can be present in the environment at background levels, a

FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information to assist in all aspects of drug marketing and regulation

Mellace Family Brands California, Inc. of Warren, OH has issued a recall for Wegmans Deluxe Mixed Nuts Unsalted 34 oz Tubs and Wegmans Deluxe Mixed Nuts Unsalted 11.5 oz bags because they have the potential to be contaminated with Salmonella

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 02/17/2023
Short Title (70 char) BlendHouse LLC. Reading, PA. EIR issued 02/17/2023
FEI Number 3015728839
Firm Name BlendHouse LLC
Record Type EIR
State PA
Establishment Type Manufacturer

Maquet is updating Servo Ventilator instructions due to a risk of inaccurate tidal volume delivery when the extended leak test is used.