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

Posted 25 April 2012 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 analysisalso 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.


Read more:

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

Share this article:

Categories: Quality

Tags: Written Procedures, Batch Failure, QA, QC, Latest News, warning letters, regulatory

Regulatory Exchange: Latest Updates From the Community