Biopharmaceutical firm Biocon Biologics said on July 21 that it was issued 8 observations by the US Food and Drug Administration (FDA) at its Insulins Manufacturing Facility in Malaysia.
The US FDA issued a Form 483 — a form listing violations — after inspections between July 10 and July 20 this year.
The FDA issues a Form 483 if its investigators spot any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.
The US drug regulator issued 6 observations for Drug Substance, Drug Product units and Quality Control laboratories and 2 observations for the Delivery Devices unit of Biocon Sdn Bhd, Malaysia, a subsidiary of Biocon Biologics.