The United States Food and Drug Administration (USFDA) issued Form 483 to Aurobindo Pharma over observation on it's two units of Hyderabad.
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. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant.
USFDA inspected Unit V, API manufacturing facility at Pashamylaram, Hyderabad and Unit VIII, API manufacturing facility at Gaddapotharam, Hyderabad of the Company from 21st to 28th October 2019 and from 21st to 25th October 2019, respectively. At the end of the inspections, we have been issued a 'Form 483' with 4 observations for each facility.
Aurobindo’s Unit-IV is a dedicated manufacturing facility for generic sterile injectables, opthalmics, and low volume parenterals.
Company said, "We believe that these observations are related to procedural improvements and none of the observations are related to data integrity. The Company will be responding to USFDA as per the prescribed time lines. With respect to Unit IV, formulation manufacturing facility at Pashamylaram, Hyderabad, the inspection is in progress. "
