Biocon Ltd. has received an Establishment Inspection Report from the U.S. Food And Drug Administration after inspection of its small molecules manufacturing facility in Bengaluru, the drugmaker said today.
The facility was inspected between Feb. 20 and Feb. 26 for post-approval and good manufacturing practices, a company spokesperson said in an exchange filing. "The EIR has been closed with a voluntary action indicated classification for the observations.”
At the conclusion of the inspection last month, the U.S. FDA had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the company, the filing said.
"We remain committed to global standards of quality and compliance," the company spokesperson added in the statement.
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