Mylan plant hit with FDA Form 483 for cleaning practices

Jul 02, 2018

A West Virginia plant owned by Mylan Pharmaceuticals has been issued a 32-page FDA 483 form for “numerous instances” lacking “appropriate oversight.” 

The form was reportedly issued by agency inspectors for observations made between March 19 and April 12 of this year. The FDA told Mylan that the company “failed to adequately validate its cleaning processes of all manufacturing equipment and utensils shared between … 230 oral dosage drug products — potent and non-potent — to ensure no cross-contamination of active ingredients and detergent occur between products.”   

In a statement, Mylan said it is committed to a “robust improvement plan” for the site.

In April, the company announced that it is cutting 500 jobs at its West Virginia plant and said the layoffs were “consistent with discussions it was having with the FDA.” But Mylan did not disclose if the recent inspection played a direct role in the cuts.

Prior to the layoffs, the company employed 3,500 at the plant.