FDA inspection uncovers cherry-colored antibiotic residue on equipment at Teva's New Jersey site
An FDA inspection report on Teva’s manufacturing site in New Jersey has revealed issues with both equipment cleaning and quality.
The three-page report, which was obtained by Endpoints News via a FOIA request from the FDA, showed several observations from its inspection, which took place between Nov. 1 and Nov. 10 of last year, at Teva’s site in Fairfield, NJ.
Inspectors noted a buildup of “unknown residue” within two production rooms that had been documented as cleaned. Specifically, a pink- or red-colored residue was found on equipment in the mixing room that had most recently been used to manufacture Cefadroxil tablets. Cefadroxil, which is used to treat bacterial infections in various parts of the body, does not use any dyes or flavorings.
To read Endpoints News become a free subscriber
Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters