Tag: FDA

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batch recall of atovaquone oral suspension due to bacterial contamination

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

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

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,...
FDA Issues Warning Letter Due to cGMP Violations

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....
Cleaning Validation of Equipment in Pharmaceutical Industry

Cleaning Validation In the Pharmaceutical Industry

Explore the essentials of cleaning validation in the pharmaceutical industry, including all necessary steps, challenges, and regulatory standards....
Good Documentation Practice - FI

Good Documentation Practices in the Pharmaceutical Industry

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

FDA Releases New Draft Guidance on Quality Considerations for Topical Ophthalmic Drug Products

Explore the FDA's latest draft guidance for top-notch quality in topical ophthalmic drug products. Stay informed on key considerations for...
GMP Regulatory Bodies

GMP Regulatory Bodies: Understanding the Key Differences

Explore global GMP standards with regulatory bodies like FDA, EMA, and WHO. Ensure compliance for pharmaceutical quality and safety worldwide....

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