FDA Warning Letters in 2011 Mostly Focused on Batch Failures

Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures - RAPS - News - Article View:

"An analysis of US Food and Drug Administration (FDA) warning letters issued in 2011 shows the majority of all facilities receiving a warning letter were deficient in areas relating to batch failure investigation, reports In-Pharma Technologist.

“In the manufacturing-related warning letters analyzed by in-Pharma Technologist, FDA made 211 numbered observations,” of which 10% were related to the company not investigating batch failures."

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• 2011 FDA Warning Letter Review (drughealth.blogspot.com)