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GMP News

FDA issues final Guidance on Remote Oversight Tools

The FDA has published a final Guidance Document on the possible use of alternative methods in the preparation of inspections or even in place of inspections for pending marketing authorisation applications.

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Four Warning Letter concerning CAPA and Root Cause Analysis published

Again, four Warning Letters from the FDA were published, criticising not only inadequate Quality Oversight but also the Root Cause Analysis and CAPAs implemented. One company in India and three in the USA were affected.

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Warning Letter due to Particles in Infusion Bags

During an inspection at the indian production site of an american sterile manufacturer, the FDA found numerous GMP deficiencies. The contamination of sterile infusions bags by particulates was a serious problem.

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