OOS Result Handling Continues as Dominant Theme in FDA Warning Letters Issued Abroad

Giving adequate attention to out-of-specification (OOS) results in batch release decision making and investigation follow up continues as the dominant theme in 2011 in GMP warning letters issued to foreign companies by FDA’s drug and biologic compliance offices.

In addition to warning letters that have been issued to China-based API supplier Ningbo Smart Pharmaceuticals and to the Indian API and generic drug manufacturer Aurobindo Pharma (IPQ “In the News” June 13),  the other five warning letters FDA has posted to date for 2011 referencing foreign inspections all share this common theme.

The recipients include: ● Stockholm Sweden-based Octapharma, regarding the production of its intravenous immune globulin G (IgG)  ● Teva Pharmaceuticals regarding its tablet manufacturing facility in Jerusalem, Israel ● Moehs Iberica, an API manufacturer located in Barcelona, Spain ● Dr. Reddy’s, regarding its production of APIs in Morelos, Mexico, and ● Sanofi Aventis, regarding its production of injectable recombinant insulin in Frankfurt, Germany.

[More analysis of the dominant concerns in the recent foreign warning letters is provided for subscribers here.  Nonsubscribers may purchase the full story for $195 by contacting Karen Bertani (Jonathan@ipq.org).  For subscription/license information, click here.]