U.S. FDA targets Eli Lilly factory again citing quality control issues

U.S. FDA targets Eli Lilly factory again citing quality control issues

U.S. Food and Drug Administration (FDA) has reportedly found new quality-control problems at an Eli Lilly & Co. unit in Branchburg, New Jersey, that is already under fire for manufacturing lapses by federal investigative officers.

These findings documented by the U.S. FDA department were brought to the fore after a gap of nearly three years since the first batch of quality issues were reported at the same plant.

Interestingly, in 2021, the U.S. Department of Justice initiated a criminal investigation after receiving repeated claims of spurious manufacturing processes and data fabrication at the facility by credible sources.

Presently, representatives from FDA visited the plant again in July 2022 and stayed for about 12 days. Over the duration of their stay, the officers found that company personnel did not track the state of potentially contaminated drug batches in a judicious manner. These batches were due to be inspected thoroughly by the quality control department of the pharmaceutical company.

Following the investigation, the inspectors issued a written statement claiming that Eli Lilly personnel identified unknown debris in a production area that was not adequately controlled as it had not been effectively scrutinized by the quality-control unit. Generally, in accordance with the regulations cited on FDAs official website, inspectors are liable to issue 483 forms under such circumstances wherein they encounter scenarios that breach federal regulations.

Notably, these drug batches included traces of the most commonly used diabetes medicine Trulicity, cancer treatment medicines Cyramza & Erbitux, as well migraine medicine Emgality.

Elaborating on this issue, former head of the Manufacturing and Product Quality Department of the FDA, Steve Lynn states that the FDA is stopping Eli Lilly from shipping their drug batches ahead of time without proper approvals from quality control.

Credible analysts are of the viewpoint that if the issues at the facility are not fixed at the earliest, the FDA may issue a warning letter and subsequently escalate the matter by ordering the facility to cease production activities for certain drugs.

Source Credits: - https://health.economictimes.indiatimes.com/news/pharma/u-s-finds-new-quality-problems-at-lilly-drug-factory/94789275