Tag: FDA

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 safety. Issues ranged from inadequate testing of drug products to…

FDA issues a Warning Letter to Diamond Chemical Co., Inc. for cGMP violations, highlighting deficiencies in component testing, batch release, process validation, and stability testing. Explore the corrective actions and…

Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria.

FDA's 2024 guidance on nitrosamine impurities introduces new limits, testing methods, and timelines, focusing on NDSRIs to enhance drug safety and compliance.

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

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

FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification.

Explore the essentials of cleaning validation in the pharmaceutical industry, including all necessary steps, challenges, and regulatory standards.

Explore effective strategies for maintaining clear and comprehensive records with our guide on good documentation practices, ensuring accuracy and reliability.