FDA Cites Wockhardt's U.S. Plant for Familiar QC and Data Trail Woes

Jun 05, 2014

money control

The FDA has found as many as 12 procedural lapses in India drugmaker Wockhardt's U.S. facility during a multiple visit FDA inspection carried out between January 22 and March 26 this year.

The Illinois-based Morton Grove Pharmaceuticals unit, which accounts for more than 50 percent of Wockhardt's U.S. sales, was issued a Form 483 for many issues that were similar to those found at a now-banned Sun Pharma facility in May, where the FDA came down on the India drugmaker's practice of “unofficial testing” of samples and disregarding of the results.

In addition to sanitation issues, quality control procedural issues and a lack of cGMP training for employees, the inspection of the Wockhardt U.S. plant revealed a failure to document the results of several "trial injections" and out of spec investigations.

FDA inspectors also pointed out that the plant was not properly monitoring/securing access to computer systems containing master production and control records -- meaning any user could delete raw data if inclined.

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