US FDA inspects Alembic Pharma’s Vadodara plant

Alembic Pharmaceuticals said no observations were issued by US health regulator US FDA after inspection of its Vadodara facility. The bio-equivalence facility was inspected by US Food & Drug Administration (US FDA) from March 6-10; March 13-17 and April 10-12, Alembic said in a filing to the Bombay Stock Exchange."There were no 483s issued by

"There were no 483s issued by USFDA at the end of the inspection," it added.US FDA issues Form 483 observations to a firm’s management at the conclusion of an inspection to notify it of objectionable conditions at the facility.

US FDA issues Form 483 observations to a firm’s management at the conclusion of an inspection to notify it of objectionable conditions at the facility. It is issued when

It is issued when investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.