USFDA inspection: Laurus Labs arm gets 5 observations for AP facility
Hyderabad: Laurus Synthesis Private Limited (LSPL), a wholly owned subsidiary of Laurus Labs, has received a Form 483 with five observations from the United States Food and Drug Administration (USFDA) for the manufacturing facility in Parawada, Anakapalli, near Visakhapatnam, Andhra Pradesh.
The inspection was conducted from 4th December, 2023 to 12th December, 2023.
"We have been issued a Form 483 with five observations, and the Company will address the observations within stipulated timelines," the Company stated in a BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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Medical Dialogues team had earlier reported that the USFDA had concluded a PreApproval Inspection (PAI) with one observation at the manufacturing facility of Laurus Labs at Unit-5, Parawada, Visakhapatnam, Andhra Pradesh.
Read also: Laurus Labs gets 1 USFDA observation for Visakhapatnam facility
