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Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures

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By Alexander Gaffney

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.

Despite only 10% of all observations being about batch failures, almost half of all facilities receiving a warning letter were cited for “failure to thoroughly investigate batch failure,” notes in-Pharma Technologist.

In-Pharma Technologist’s analysis also noted that an additional third of all companies receiving warning letters were warned after FDA found they did not have written procedures to ensure quality.


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In-Pharma Technologist - Half of FY11 FDA GMP warning letters tied to batch failures




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