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FDA issues a warning letter to Linghai ZhanWang for failing raw material testing, stability studies, and quality oversight, placing its...
CGMP violations identified in the FDA Warning Letter to Marshalls Traditional Healthcare CC, including deficiencies in finished product testing, process...
FDA warns ABR Laboratory LLC for failing to validate test methods and investigate deviations, risking drug safety. Learn key compliance...

On January 30, 2025, the FDA issued a Warning Letter (320-25-37) to Strukmyer LLC dba Strukmyer Medical, following an inspection...

FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation...
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and...
Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health....
he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer...
FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release,...
Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria....

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