Lilly Retains Outside Consultant to Help After Inspections
Eli Lilly says it has retained an outside consultant to “conduct a comprehensive independent review of systems” at its Branchburg, NJ site, following two inspections over the past year that have cited significant GMP concerns. The facility has been designated as one of several that will manufacture the company’s bamlanivimab neutralizing IgG1 monoclonal antibody as monotherapy in higher-risk patients who have recently been diagnosed with mild-to-moderate Covid-19 (see earlier story), for which it is seeking an emergency use authorization. Bamlanivimab is similar to Regeneron’s investigational antibody cocktail REGN-COV2 that president Trump was given after contracting the coronavirus earlier this month.
The Lilly plant was first inspected last November and its Form FDA-483 detailed numerous inspection findings, according to Reuters which reviewed the heavily redacted form (see story). For example, the FDA-483 says data on the plant’s various manufacturing processes had been deleted and not appropriately audited. “The deleted incidents and related audit trail were not reviewed by the quality unit,” FDA inspectors wrote. Lilly did not always have proper laboratory controls for drugs manufactured at the plant, the FDA-483 says. One source told Reuters that the plant failed to maintain systems meant to ensure that a popular anti-migraine drug, Emgality, met strength and purity standards.
A Bloomberg report details inspection-related documents it obtained, including a 10/2 memo authored by FDA compliance officers who wrote that the findings from the recent inspection “support a major failure of quality assurance.” They noted that although the facility will make the Covid-19 therapeutic, the inspection group “feels it is still imperative that FDA take action.” The compliance officers recommended that the company receive a Warning Letter.
The inspection documents say agency inspectors found that in some cases Lilly employees didn’t investigate potential quality problems and routinely overrode testing systems, according to Bloomberg. “In one case described by FDA inspectors, a Lilly employee allegedly used the wrong material in a critical purification step. In another, after routine checks revealed a potential impurity in a drug product, an employee retested it to get a passing result, according to the documents, instead of attempting to figure out why there were signs of an impurity in the sample,” the report said.
A confidential informant told FDA that Lilly managers documented more details of quality concerns that required personnel action in the company’s human-resources system, according to the 10/2 memo that Bloomberg reviewed. Agency inspectors said in their report that they repeatedly asked to review the human-resources records, but said Lilly refused to grant them access.
Lilly has confirmed that the 11/2019 inspection was classified by FDA as official action indicated. “The issues raised during the Branchburg inspections have our full attention and we have been working closely with FDA on remediation efforts,” the company says, adding that “we have increased staffing and resources at Branchburg to manage the additional activity levels we are experiencing related to production of active pharmaceutical ingredients. We are confident that the issues raised during the Branchburg inspections did not impact product quality or patient safety. While Lilly has not received a Warning Letter or other enforcement letter from the FDA related to this matter, we nevertheless take all FDA inspection findings very seriously and are urgently working to address their concerns.”