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.
Previously, the same equipment also produced several batches of Cephalexin, another antibiotic which does include a cherry flavoring and a red dye, FDA said. Cephalexin is used to treat pneumonia, respiratory infections and others.
The report also indicates that several other areas of the mixing room contained unknown residue, including a workstation and several blenders, one of which had previously been used to make Cephalexin capsules.
The inspection report also said that some Cephalexin tablets had two complaints attached, which was part of a larger investigation into “defective coating.” As part of the investigation, the batch was subjected to other tests, but was also run through screening equipment that was not documented as “qualified with tablet products.” The report and the standard operating practices don’t give details on the screening of tablets. While over 34,000 tablets were rejected, the remaining tablets that were scanned were released for distribution in the US in 2018.
Teva also received 30 complaints related to defective coatings on Cephalexin between Nov. 2018 and March 2021. Coating enhancements were recommended, while the implementation of these enhancements is still pending, according to the report.
Endpoints reached out to Teva for a statement on this report but did not receive a response by press time.
Teva’s manufacturing sites have been under the FDAs microscope in the past.
In 2021, investigators unveiled several problems at a Teva Pharmaceuticals plant in Irvine, CA, including mold stemming from water leaks. Teva halted production at that site, which eventually led to the recall of 2.5 million vials of drugs, according to a Bloomberg report.
That site was shuttered in August of 2022, with 305 people being laid off.