The FDA has expressed testing and quality concerns to Bayer regarding its Bergkamen, Germany, facility. The concerns relate to released API batches used in drugs intended for the U.S. market.
The just-released letter dates from early August, and it follows an FDA inspection of the facility in March. Inspectors found "significant deviations" from good manufacturing practices.
Bayer responded to the findings in April, outlining the steps it planned to take to bring the facility back up to snuff. The August FDA response recaps initial findings and acknowledges the corrective actions Bayer described, but also notes that some deficiencies remain. Among them: out-of-spec results that Bayer contends are "within the accepted variation of the analytical method" used and product quality was unaffected.
"We disagree with your rationale and conclusion," the regulator writes. "We believe these batches should not have been released for distribution."
A Bayer spokeswoman this week said the company is analyzing the points raised in the FDA letter, according to a Reuters report. "At this point, we have identified no safety and efficacy impact on our products in relation to the issues cited by the FDA."