The Eli Lilly And Co (NYSE:LLY) plant being readied to make an antibody therapy for COVID-19 has been found to have serious quality control problems by the United States Food and Drug Administration, Reuters reported Tuesday.
What Happened: As per government documents, two inspectors who visited the drugmaker’s Branchburg, New Jersey plant last November, found that data on various manufacturing processes had been deleted and not audited properly.
An “Official Action Indicated” notice was issued, which is indicative of the most serious level of violation, according to Reuters. The inspectors returned to the plant in August and found additional issues.
Patricia Zettler, a former chief counsel at the FDA told Reuters that “violations are serious enough and have a significant enough impact on the public health that something needs to be fixed.”
Eli Lilly confirmed the OAI notice to Reuters but said the data deletions were not related to the production of the antibody cocktail.
The company said it had launched a remediation plan and increased staffing at the site and was working “aggressively” to address FDA concerns.
“These findings do not impact product quality or patient safety, as outlined in a detailed assessment submitted to FDA,” the drugmaker said in a statement.
Why It Matters: A warning letter could be issued to the drugmaker and it could be given a deadline to fix the issues by the FDA failing which it could be barred from manufacturing certain drugs at the plant, noted Reuters.
The drugmaker has reportedly not disclosed the FDA inspections in its filings with the U.S. Securities and Exchange Commission.
On Monday, Eli Lilly separately paused its government-sponsored Phase 3 clinical trial for its antibody treatment due to a “potential safety concern.”
The drugmaker, along with Regeneron Pharmaceuticals Inc (NASDAQ:REGN), has applied for an Emergency Use Authorization for the drug.
The drug, still not approved by the regulators, has been touted as a “cure” by President Donald Trump after he was administered a similar treatment made by Regeneron.
Regeneron CEO Leonard Schleifer said this week that more testing was needed for the antibody cocktail to measure its efficacy.
Price Action: Eli Lilly shares closed 2.85% lower at $150.08 on Monday.
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