FDA Cites Eli Lilly Manufacturing Facility for Quality Control, Falsified Documents: Reuters

Federal investigators have identified a number of production and quality control violations at an Eli Lilly manufacturing plant, which makes several widely used medications that treat migraines, diabetes, and cancer.

The U.S. Food and Drug Administration (FDA) found several manufacturing and quality control problems in Eli Lilly’s Branchburg, New Jersey facility, following inspections conducted in July 2023, according to a Reuters report published last week. The facility manufactures several medications, including Emgality (galcanezumab) for migraine prevention, Trulicity (dulaglutide) to treat type II diabetes, as well as cancer treatment drugs Erbitux (cetuximab) and Cyramza (Ramucirumab).

The inspection report comes as Eli Lilly seeks to capitalize on the success of its diabetes drugs Mounjaro (tirzepatide), which is similar to the blockbuster Ozempic, and was recently approved by the FDA to be sold as a weight loss drug under the brand name Zepbound.

FDA Investigators Identify Problems at Eli Lilly Facility

Reuters indicates it obtained a report outlining the findings of an inspection from Eli Lilly’s Branchburg facility through a Freedom of Information Act Request. The inspection was conducted at the request of Eli Lilly, after asking the FDA for permission to manufacture Emgality on a different production line if needed in the future. Following the request, FDA investigators inspected the plant in July 2023, and found eight separate violations.

According to the Reuters report, inspectors found discoloration on a container used to purify active drug ingredients, which regulatory experts say can lead to contamination issues. The overall appearance of the facility and its equipment suggested neglect, a government official with manufacturing process knowledge told Reuters.

The report indicates inspectors found inadequate training among staff who were testing drug samples. Employees were not properly trained to document the drug samples taken for testing, which is required to show the medications are stable before they are released to the public. Eli Lilly failed to address the missing samples in a timely manner.

Another serious violation included failure to maintain and protect the electronic records detailing its manufacturing process, lab activities, and test results. Former FDA official, Steven Lynn, told Reuters the electronic tracking system issue is a major concern, as it is meant to ensure test results and lab activities cannot be manipulated once submitted.

In a statement made to Reuters, Eli Lilly said the investigator’s concerns were either addressed during the inspection, or are currently being addressed now. The drug maker went on to say only Emgality was impacted by the inspection, and the situation does not affect any other products.

Eli Lilly Manufacturing Problems

This is not the first time Eli Lilly has come under scrutiny from the FDA for poor manufacturing practices. The report indicates several of the company’s manufacturing plants across the U.S. have been cited multiple times for several violations, including the Branchburg facility.

The Branchburg facility in particular has been under investigation by the U.S. Department of Justice since 2021 for poor manufacturing processes and falsifying data, according to the report. During a routine inspection conducted in November 2019, FDA investigators found the company failed to keep quality management records, and red-flagged other manufacturing problems.

During a subsequent inspection of the facility in July 2020, inspectors found that when sample testing of Emgality showed potential problems, the company repeated the tests until it produced the results needed to complete the manufacturing process, instead of addressing the issue. Investigators also found the plant had to discard a large batch of drug ingredients that had been used incorrectly in May 2020,.

The facility had been cited for similar violations at least three other times in 2020 alone, and the agency could not determine if the problems had been properly addressed.