FDA Discovers Quality Control Problems At Eli Lilly Plant Manufacturing Potential COVID-19 Drug

Inspectors from the U.S. Food and Drug Administration (FDA) discovered serious quality control problems at an Eli Lilly and Co manufacturing facility in Branchburg, New Jersey. The drug maker manufactures one of the potential COVID-19 drugs touted by Donald Trump as a cure for the disease.

FDA inspectors who visited the facility found that data on the plant’s manufacturing processes had been deleted and not properly audited. According to an FDA report, the deleted incidents and related audit trail were not reviewed by the quality unit and could be classified as serious violations. Sources also said Eli Lilly employees had complained about problems at the facility, including insufficient staffing and fabricated records tracking whether workers had followed FDA manufacturing standards.

The issues identified resulted in an “Official Action Indicated” (OAI) notice, which means “the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,” said former FDA associate chief counsel Patricia Zettler.

Eli Lilly confirmed the issuance of the OAI notice but refused to provide details on what had prompted the FDA action. However, the company revealed it had launched a “comprehensive remediation plan” to address all the concerns raised during the FDA inspection and increased staffing at its New Jersey site.

The company also claimed that the data deletions cited by the FDA were not related to the production of its COVID-19 drug. “These findings do not impact product quality or patient safety, as outlined in a detailed assessment submitted to FDA,” said the company in a statement. “Lilly continues to provide updates to the FDA on progress towards completion of our detailed plan.”

On Tuesday, Eli Lilly said it had halted the clinical trial for its coronavirus drug in hospitalized patients “out of an abundance of caution” over a possible safety issue. The company did not disclose the details of the problem and declined to comment on how the incident might affect its request for a so-called emergency use authorization (EUA).

Legal experts said the uncovered issues could complicate the pharmaceutical company’s bid for EUA from the FDA, as U.S. law requires compliance with manufacturing standards for the authorization of any drug.