NEW YORK (AP) — Generic drug developer Mylan Inc. said Tuesday the FDA backed up the company’s position that employees at a West Virginia facility did not ignore quality control procedures, though the agency disputes the company’s claim. Mylan said FDA investigators found that claims in a lengthy investigative piece by the Pittsburgh Post-Gazette were unfounded. The agency, though, said that was not the case and the FDA has yet to form a conclusion. Any statement implying so, is “untrue,” the agency said. “The investigation is ongoing and the agency has formed no conclusions at this time. Statements to the contrary are untrue,” said Steven Solomon, the agency’s assistant commissioner for compliance policy. He said the investigation involves “allegations of compliance violations that the FDA takes very seriously.” On Sunday, the Pittsburgh Post-Gazette published an article saying the company discovered workers routinely ignored warnings about potential problems in the production process at a Morgantown, W.Va. facility. Mylan shot back with a statement the same day disputing the article. Mylan said FDA officials visited the facility Monday after the company’s “proactive” contact and noted there was no evidence of any data deletion in regard to the quality controls. “All data was reviewed and was present and accounted for; the agency agreed that this was a minor standard operating procedure deviation that existed, was fully investigated, and all corrective actions were fully implemented by Mylan,” the company said in a statement.
