HT Team
October 18, 2022: The USFDA has inspected India’s Alembic Pharmaceuticals’ Oncology Injectable Formulation Facility at Panelav, Gujarat, according to a BSE filing.
The inspection lasted from October 4, 2022, to October 14, 2022.
“The USFDA issued a Form 483 with four procedural observations. None of the observations is related to data integrity, and management believes they are addressable.”
An FDA Form 483 is issued to firm management after an inspection when an investigator has observed any conditions that, in their judgment, may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Objectionable conditions
The FDA Form 483 notifies the company’s management of objectionable conditions. After an inspection, the FDA Form 483 is presented and discussed with the company’s senior management.
Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and implement it expeditiously.
The company is preparing a response to the observations, which it will submit to the USFDA within the stipulated period.
Alembic is committed to maintaining the highest quality standards and compliance at all times, according to the filing.
In February this year, the US Food and Drug Administration (USFDA) decided to restart an old pilot project, conducting surprise inspections of foreign manufacturing plants.
The drug regulator has increased its inspection activity in India and plans to have more surprise or ‘short notice’ inspections.
“In terms of (inspection) activity (in India), we are getting closer to pre-pandemic levels,” Sarah McMullen, country director – India at US Food and Drug Administration, said in September.
It effectively ends the two-year reprieve from ‘warning letters’ and other regulatory measures that Indian drug makers had since the onset of the Covid-19 pandemic.
