FDA Draft Guidance: Considerations for Complying with 21 CFR 211.110
FDA's January 2025 draft on 21 CFR 211.110 outlines CGMP measures for batch uniformity, drug integrity, and advanced manufacturing innovation
FDA Transitional Enforcement Guidance for Ethylene Oxide Sterilization Facility Changes for Class III Devices
FDA announces a new policy on ethylene oxide sterilization site changes for Class III devices, ensuring supply chain stability and patient safety.
What Is Good Manufacturing Practices (GMP)?
Good Manufacturing Practice (GMP) ensures pharmaceuticals are produced consistently with high standards for quality, safety, and efficacy, protecting patient health.
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 safety. Issues ranged from inadequate testing of drug products to…
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, process validation, and stability testing. Explore the corrective actions and…
Bionpharma Inc. Recalls Batch of Atovaquone Oral Suspension Due to Contamination
Bionpharma Inc. has issued a recall for Atovaquone Oral Suspension due to contamination with Cohnella bacteria.
FDA Releases Updated Guidance on Controlling Nitrosamine Impurities in Human Drugs
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 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 steps for compliance.
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, and labeling issues.
FDA Issues Warning Letter Due to cGMP Violations
FDA issues warning to for CGMP violations. Addressing insanitary conditions, quality control, lab testing, and component verification.