Biocon on Saturday stated that it has gained 3 observations from the US health regulator following inspection of its facility of insulin manufacturing in Malaysia.
The US Food and Drug Administration (USFDA) had performed a pre-approval inspection of subsidiary Biocon Sdn BH's manufacturing facility of Biocon in Malaysia for Insulin Glargine between February 10 and 21.
A Biocon spokesperson stated in a regulatory filing that at the conclusion of the inspection, the agency furnished a Form 483 with 3 observations which they believe are procedural in nature.
As per the USFDA, Form 483 is furnished to firm management at the conclusion of an inspection when investigators have found any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.
The company added that they will respond to the FDA with an appropriate Corrective and Preventive Action Plan (CAPA) and they are confident of addressing these observations expeditiously.
The FDA has established a target action date for its Insulin Glargine application in June 2020.
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