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USFDA observations to Biocon's Malaysia facility not serious, say analysts

Updated : March 04, 2020 02:00 PM IST

At the conclusion of the inspection, the agency had issued a Form 483 with 3 observations.
The observations received by the Biocon from the US drug regulator for its Malaysia plant are procedural and not serious, analysts said.
Analysts believe this is a positive development for the company and it does not look like anything as serious as data integrity.

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