Judul : FDA: Lilly plant making COVID-19 antibody treatment has numerous findings
link : FDA: Lilly plant making COVID-19 antibody treatment has numerous findings
FDA: Lilly plant making COVID-19 antibody treatment has numerous findings
Via Bloomberg, this unfortunate news:
U.S. drug-safety inspectors have found continuing quality-control problems problems at a New Jersey plant Eli Lilly & Co. is using to help produce its Covid-19 antibody therapy, posing a potential obstacle to the company meeting its goal of producing 1 million doses by year-end.
In an Oct. 2 memo, Food and Drug Administration compliance officers wrote that findings from an inspection of the facility in July and August “support a major failure of quality assurance.” They noted that Lilly planned to make its antibody therapy at the plant and said the inspection group “feels it is still imperative that FDA take action.”
The assessment was based on a four-week site inspection that ended on Aug. 21, the details of which haven’t previously been reported. The compliance officers recommended that the company receive a warning letter, one of the agency’s strongest enforcement measures, according to documents reviewed by Bloomberg News. Agency inspectors found that in some cases Lilly employees didn’t investigate potential quality problems and routinely overrode testing systems, according to the documents.
...At that time, inspectors found the company’s system for tracking manufacturing quality wasn’t secure and could be accessed and modified by anyone, according to the documents reviewed by 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.Lilly managers downplayed quality missteps in a data-management system FDA has access to during inspections called TrackWise, according to inspection documents. Drugmakers use such workflow tracking systems to record the outcomes of quality checks during the manufacturing process.
A confidential informant told the FDA that Lilly managers documented more details of quality concerns that required personnel action in the company’s human-resources system, according to the Oct. 2 memo. Agency inspectors said in their report that they repeatedly asked to review the human-resources records, but said Lilly refused to grant them access.
It's very surprising to me that there was a computer system without an audit trail in a facility that manufactures a biological. I'd really like to understand the context around the mis-charge of material - I would presume there were about 7 deviations to get there, but I dunno...
I'm looking forward to more context from the inevitable warning letter.
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