Oct 4 (Businesshala) – Eli Lilly & Co. (LLY.N) recently recalled batch of therapy, a glucagon emergency kit for diabetic patients in crisis, cited by US health regulators this year for quality-control violations in Indiana was manufactured in the factory, according to a Businesshala review of company and federal inspection records, including several that contain that product.
The Indianapolis-based company released September 24 Voluntary US Recall One of several kits whose key ingredient is glucagon, a drug used to treat dangerously low blood sugar in patients with diabetes. company issued voluntary recall in canada next day.
Lilly’s recall notice said the company had received reports of a patient who experienced seizures even after injecting the drug, a sign that the treatment was not potent enough to work. The company said the product failure could be related to its manufacturing process, without elaborating.
In response to inquiries from Businesshala, Lilly told the news organization that the affected kits were produced at a company facility in Indianapolis, and that the kits were distributed in Canada for recall. As Businesshala reported in May, the Indianapolis plant was cited by US health regulators for shoddy sanitation and quality control procedures.
Separately, Lilly is facing a federal criminal investigation into alleged manufacturing irregularities involving another of its US factory in New Jersey, details of which were first reported by Businesshala earlier this year. The recall of glucagon kits made in Indianapolis is the first sign of potential patient harm due to recent manufacturing issues at the company’s plants.
“Lily is committed to manufacturing high quality medicines for the patients who need them – nothing is more important to us,” the company said in a statement. “We take our obligations seriously and have rigorous quality systems to ensure compliance with stringent regulatory requirements.”
In all, about 66,000 were affected by the glucagon emergency kit recall, Lilly’s spokeswoman Katherine Beiser told Businesshala. She said that about 19,000 of them were distributed to US customers and almost all of them in Canada. She said the kits were produced at the Indianapolis plant around May 2020. Beeser declined to say whether Lilly had received other reports of adverse events related to the glucagon kit.
The recalled glucagon emergency kit was designed for diabetics who have low blood sugar, and who need to raise it quickly to avoid complications that can include seizures or death. The kit consists of a vial, which supposedly contains freeze-dried glucagon powder, and a separate syringe filled with liquid.
Typically, a caregiver inserts a syringe needle filled with liquid into the glucagon vial to dilute it before administering the powder. Lilly’s recall announcement stated that the vial used by the aggrieved patient contained liquid rather than powder.
The company’s Indianapolis plant is known in the industry as “fill and finish”—receiving raw drugs, pouring them into vials and syringes, and shipping them to customers at other facilities.
US Food and Drug Administration inspection records from March 2021, seen by Businesshala, cited a number of quality-control violations at the plant, such as workers failing to properly monitor environmental conditions where the finished drugs are made and Fails to establish proper procedures to prevent contamination.
FDA inspectors said they saw flaws in the manufacturing of the glucagon kit as well as Lilly’s COVID-19 antibody therapy bamlanivimab and several other drugs, according to inspection records from March 16. He concludes that Lily must take steps to remedy. Missed but did not recommend regulatory action on the part of the FDA.
Lilly’s spokeswoman Beiser said US distribution of the glucagon emergency kit from the later recalled lots had stopped as of March 25, a little more than a week after the FDA inspection report. Beiser said the distribution of the lots followed its regular procedure through wholesaler channels and was not related to the FDA’s report, adding that “any suggestion” that it ended up for other reasons is incorrect.
Meanwhile, emergency kits from the same batch continued to be distributed in Canada, Beiser said. Distribution of 44,000 kits in Canada began in February 2021 and continued through mid-September. The patient complaint, which began in late September, involved a kit that had been shipped to Canada, Beiser told Businesshala.
Beiser declined to comment specifically on why distribution of glucagon emergency kits from the batch continued for another six months in Canada after distribution in the United States ceased. He did not respond to a question whether the affected patient had recovered.
Health Canada, a regulatory agency similar to the US FDA, declined to comment about the voluntary recall of Lilly’s Glucagon Emergency Kit, or why the kits were in Canada out of batch for months after being distributed in the United States. continued to be distributed. .
The FDA declined to comment on the distribution of the kit, whether it had received other reports of adverse events, re-inspected Lilly’s Indianapolis facility or if it planned additional actions related to the recall.
“It is important to note that this recall was a voluntary action taken by the company,” FDA spokesman Jeremy Kahn said without elaborating. “We are evaluating this incident closely and will continue to monitor market and manufacturing efforts to help ensure the availability of safe products for US consumers.”
The recall comes as Lilly faces a criminal investigation by the US Department of Justice for alleged manufacturing irregularities and record-tampering at a separate factory in Branchburg, New Jersey, which produces bamlanivimab and other drugs.
The Justice Department has not charged Lilly with any wrongdoing, and the company said earlier this year that it was cooperating with the investigation. Lilly did not respond to a question from Businesshala about the status of that investigation. The Justice Department did not respond to a request for comment.
Bamlanivimab, the COVID-19 antibody manufactured at the Branchburg facility, is shipped and shipped in vials to the Indianapolis fill-and-finish plant.
A group of FDA inspectors arrived at the Indianapolis plant in mid-February and stayed for more than two weeks, according to a revised version of their report, which Businesshala obtained via a Freedom of Information Act request.
In their report, inspectors listed glucagon as a drug where Lilly “failed to establish an adequate system for monitoring environmental conditions,” and noted that Lilly failed to establish and follow appropriate written procedures. failed “in order to prevent microbiological contamination of pharmaceutical products. Sterile.”
In addition, inspectors said Lilly did not properly handle quality-control sampling of glass components such as vials and pharmaceutical ingredients for drugs including glucagon, bamlanivimab and the cancer drug Cyramza.
In Lilly’s April 6 response to the FDA, obtained by Businesshala via an open records request, the company said it takes the inspectors’ findings “very seriously” and is implementing action to address the concerns “on an aggressive timeline”. has been
Lilly said it has established a comprehensive environmental monitoring program designed to assess microbiological control of manufacturing spaces, the revised response said. The company did not respond to questions about the status of its efforts to rectify the violations noted by the FDA at the Indianapolis plant.