The FDA today published more than 200 decision letters, known as complete response letters (CRLs).
Similar Posts
Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.FDA Clinical Trials Training Modules
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.Lunds & Byerlys Voluntary Recalls L&B Monster Cookies Due to Incorrect Labeling
EDINA, Minn., December 9, 2025 – Lunds & Byerlys is voluntarily recalling its L&B Monster Cookies as the wrong ingredient label was applied to the packaging. Packages may contain undeclared peanuts, egg, and soy. People who have allergies to peanuts, egg, and soy run theSV Labs Corporation – 716503 – 12/09/2025
CGMP/Finished Pharmaceuticals/AdulteratedSumitomo Pharma Co., Ltd. 8/7/2025 483
Record Date: 08/7/2025
Entity Name: Sumitomo Pharma Co., Ltd.
FEI Number: 3003028650
Record Type: 483
Country: Japan
Establishment Type: Drug ManufacturerSTAQ Pharma of Ohio, LLC. Columbus, OH. 483 issued 05/16/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/16/2025
Short Title (70 char) STAQ Pharma of Ohio, LLC. Columbus, OH. 483 issued 05/16/2025
FEI Number 3025336457
Firm Name STAQ Pharma of Ohio, LLC
Record Type 483
State OH
Establishment Type Outsourcing Fac
