Lilly 483 report offers insights from site making COVID antibodies

Regulatory NewsRegulatory News
| 12 August 2021 | By Joanne S. Eglovitch 

The US Food and Drug Administration (FDA) on 12 August released a Form 483 report to Eli Lilly’s sterile injectables site in Indianapolis, noting multiple quality lapses.
 
The observations follow a February to March 2021 inspection at the site, which makes several medications: bamlanivimab and etesevimab for COVID-19, glucagon for treating severe hypoglycemia in diabetic patients, and ramucirumab for non-small cell lung cancer.
 
One of the seven observations was the firm’s lax environmental monitoring controls in aseptic processing areas. “Aseptic personnel were held to Grade B specifications, even when they are performing interventions inside the Grade A area,” according to the report. Personnel also were held to Grade B specifications even when they needed to breach the aseptic Grade A area to perform environmental monitoring activities.
 
The report said that “holding personnel who breach the aseptic Grade A area to Grade B specifications resulted in inadequate trending of personnel monitoring data.”
 
The company also failed to address employee fatigue in allowing an operator to work 14 hours on a filling line. Standard operating procedures governing fatigue “does not ensure the operator maintains aseptic technique even when they are fatigued,” the report noted. Management “does not consider the time the operator is working in the aseptic B 103 vial filling line during the fatigue challenge, instead they monitor the length of the operators shift, regardless of where they are working.”
 
The company also rejected numerous glass vials from “high risk” vendors yet failed to uncover a root cause for these defects.
 
The firm also failed to adequately validate and follow procedures designed to prevent microbiological contamination of drug products. “Interventions performed during media fills do not reflect routine production. The firm normalizes the number of inherent interventions obtained for the entire year to determine the number of interventions performed” per vial, according to the report. The company also does not “trend the frequency/type of interventions occurring per batch.”
 
The Form 483 report was first reported in May by Reuters, which also reported that employees at Lilly’s Branchburg, NJ, plant accused a company quality executive of altering required FDA documents in an effort to downplay serious quality control problems.
 
Reuters also reported in March that a human resources officer at the Branchburg factory said she was forced out of her job after raising concerns about quality control, recordkeeping and staff shortages.
 
In response to the 483, Eli Lilly said in an email to Focus that, “The FDA has classified their inspection as “Voluntary Action Indicated,” and thus will not take or recommend regulatory or enforcement action. We have responded to the FDA’s observations from this inspection with appropriate actions and continue to keep the agency updated on our progress. Importantly, none of the issues raised in the FDA’s observations affected the quality of any finished product or product in the marketplace that was manufactured in this facility.”
 
Form 483 report
 
 
 
 

 

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Tags: 483, Eli, FDA, Form, Lilly

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