FDA warns Mylan Laboratories for critical cGMP violations in quality control, data integrity, and governance, urging urgent corrective actions to...

News, Warning Letters

November 3, 2024

FDA Warning Letter: MedOffice Saglik Endustri Anonim Sirketi

he FDA inspection at MedOffice Saglik Endustri Anonim Sirketi revealed significant CGMP violations that could jeopardize product quality and consumer...

News, Warning Letters

October 1, 2024

FDA Warning Letter Analysis: Diamond Chemical Co., Inc.

FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release,...

News, Warning Letters

August 13, 2024

FDA Issues Warning Letter to LS Promotions Inc. for cGMP Violations

FDA issues warning to LS Promotions Inc. for significant cGMP violations. Learn about the key deficiencies, recommended CAPA plan, and...

News, Warning Letters

July 19, 2024

FDA Issues Warning Letter to Chinese Medical Device Manufacturer for GMP Violations

FDA issues warning letter to Chinese medical device manufacturer for GMP violations, including CAPA failures, inadequate investigations, poor design validation,...