Post-Warning Letter Meetings Under GDUFA

FDA recommends that ingestible fluoride drug products – typically available as tablets and drops – should be limited to children aged three years and older who are at high risk for tooth decay.

LLK TRADING INC. of Linden, NJ, is recalling its 200g packages of “Needle Mushrooms” because it has the potential to be contaminated with Listeria monocytogenes

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 09/05/2025
Short Title (70 char) North American Custom Laboratories LLC dba FarmaKeio Superior Custom Compounding. Richardson, TX. 483 issued 09/05/2025
FEI Number 3014229024
Firm Name North American Custom Labo

Shilpa Medicare Limited – 11/21/2025. Country: India. Record Type: 483

Cottonwood Heights, Utah (February 26, 2026) Go Raw LLC is expanding its February 17, 2026, voluntary recall of a freeze-dried product to add two lots of select Quest Cat Food Chicken Recipe frozen products due to potentially low levels of thiamine (Vitamin B1).
The two lots of Quest Cat Food Chicke

Clinical Outcome Assessments (COA) Qualification Program Submissions