The biotech was slapped by the agency after inspectors visited a manufacturing facility last June in France, where Genzyme makes Thymoglobulin, which is used to treat acute rejection in organ transplant recipients, according to a Sept. 19 warning letter from the FDA.

Genzyme employees on “several occasions” continued to use components that failed to meet limits on pathogenic microorganisms, according to the FDA letter. The final med all specs, “however, based on FDA’s experience, there is a high probability that the observed (manufacturing) deviations, if not corrected, would substantially increase the risk” that future batches would fail to meet production standards, the FDA wrote.

The agency told Genzyme to correct those problems and others documented during the inspection. The letter noted that Genzyme had responded to some of the inspectors’ observations. “However, we believe that your response did not provide sufficient detail to fully assess the adequacy of the corrective actions,” according to the letter.