14/15 September 2021
A review of the 2013 FDA Warning Letters shows that the incorrect handling of OOS results is still a hot topic in FDA inspections and inspection follow up activities (483s, etc.). In total 9 companies received a FDA Warning Letter relating to OOS investigations in the calendar year 2013. Here are some examples of these OOS citations:
To find more of these please see the 2013 FDA Warning Letter OOS citations.
According to these citations giving adequate attention to out-of-specification (OOS) results in batch release decision continues as one of the dominant themes in 2013 FDA Warning Letters.
In order to assist the pharmaceutical industry in a FDA/GMP-compliant handling of OOS Results the ECA Quality Control Working Group established a general SOP for the handling of OOS results. This SOP will be presented in the ECA OOS Training Course on 11-12 March 2014 in Vienna, Austria