Last Updated on October 9, 2024 by The Health Master
The U.S. drug regulator has flagged three procedural lapses in a pre-approval inspection at Zydus Lifesciences Ltd.’s manufacturing facility SEZ-1, located in Ahmedabad.
“The U.S. Food and Drug Administration (USFDA) conducted an inspection at the manufacturing facility SEZ-1 of Zydus Lifesciences Ltd., located at Pharmez, Ahmedabad, from March 20 to 24, 2023,” the company had said in a March 30 exchange filing.”
“The inspection was a pre-approval inspection as well as a good manufacturing practices audit and concluded with three observations.”
This will involve the issuance of a Form 483, which is issued when investigators have observed any condition that, in their judgement, may constitute a violation of the Food, Drug, and Cosmetic Act and related acts.
“There were no data integrity-related observations,” the company said. Zydus Lifesciences is addressing these observations and will respond to them within the stipulated time, the company said.
BQ Prime has obtained a copy of the three observations from the USFDA.
These are:
- Equipment and utensils are not cleaned and maintained at appropriate levels to prevent contamination that would alter the safety and quality of the drug product. Specifically, the cleaning of manufacturing equipment and its verification for cleanliness are inadequate.
- Failure to review an unexplained discrepancy, whether or not the batch has been distributed. Three inadequate investigation incidents were noted.
- Laboratory controls do not include the establishment of appropriate test procedures to ensure products conform to certain standards. In particular, the quality unit lacked adequate oversight on the use of qualified reference standards in the validation of analytical methods and testing of drug products filed in U.S. markets. Five instances were observed.
Zydus Lifesciences has yet to respond to BQ Prime’s emailed queries on the implications of the observations and the impact on the pending approvals and launch timelines.
It’s also yet to comment on the steps being taken to address these issues and the expected timelines for resolution.
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