Eli Lilly’s beleaguered manufacturing site in Branchburg, New Jersey, is back in the U.S. Food and Drug Administration’s crosshairs, Reuters first reported.
The latest round of scrutiny, which the news service uncovered through a Freedom of Information Act request, comes several years after Lilly received a subpoena from the federal government centered on quality control issues and possible document tampering at the site.
Now, following a July inspection at Branchburg, the FDA has flagged eight new production deficiencies, according to Reuters. The observations run the gamut from problems in tracking manufacturing processes and quality controls to equipment calibration lapses and poor facility maintenance, the news service reports.
Lilly confirmed its receipt of the manufacturing write-up in an email to Fierce Pharma.
Prompting this round of scrutiny, Lilly had requested “additional flexibility” from the FDA to produce the migraine med Emgality on a different production line, if needed, the company's spokesperson said.
That request triggered an inspection, which "resulted in some observations that were, in most cases, either addressed during the inspection or already in progress as program improvements," Lilly said.
The company stressed that the situation "does not affect the quality, safety or supply of any current or planned Lilly products in the marketplace."
The Branchburg facility is currently classified by the FDA as Voluntary Action Indicated (VAI), the spokesperson explained. That designation means the FDA found objectionable conditions or practices during its inspection but stopped short of taking formal administrative or regulatory actions.
Among the problems uncovered during the FDA’s summer inspection was inadequate protection of electronic records on Lilly’s manufacturing process, which could leave the company vulnerable to data manipulation, Reuters pointed out.
Inspectors also flagged inadequate staff training for workers testing samples of drugs, plus, maintenance of the facility and equipment overall was poor.
Problems at Lilly’s Branchburg site stretch back to at least 2021, when Reuters first reported employees at the site had accused an executive of altering FDA-required documents in a bid to downplay quality control problems.
Shortly thereafter, the Department of Justice handed down a subpoena linked to the Branchburg site, which had been producing doses of Lilly’s COVID-19 antibody treatment.
In October 2022, Lilly received another reprimand at the site after FDA investigators found Lilly workers failed to adequately track potentially contaminated drug batches meant to be inspected by the company’s quality control unit.
Branchburg has also been at the center of a recent Eli Lilly whistleblower lawsuit.
In 2022, plaintiff Amrit Mula sued the company claiming she was unjustly fired for reporting problems linked with the production of blockbuster diabetes drug Trulicity. The following summer, the parties told the courts they’d reached a tentative agreement, though they indicated they needed some “additional time to conclude the agreement.”
Mula and Lilly agreed to settle in September.