Biocon's Malaysia Inspection Yields 6 Observations
Biocon has issued a statement to the stock exchanges that the US-FDA completed a pre-approval inspection of its manufacturing facility in Malaysia and issued a Form 483 with six observations.
“As per the normal process, the company has already submitted the Corrective and Preventive Action Plan (CAPA) to address these observations to the regulator,” the Biocon spokesperson said on Feb 21, 2018.
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