The US drug regulator, after inspecting the two sites, had expressed
concerns over quality-control procedures that include handling of
out-of-specification results and conducting hold-time studies.
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/plan-to-approach-usfda-for-re-inspection-of-key-plants-in-next-few-months-lupin/articleshow/76367915.cms
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