Latest News | USFDA Issues Form 483 with Five Observations to Torrent Pharma Unit

New Delhi, Jun 12 (PTI) Torrent Pharmaceuticals on Wednesday said the US health regulator has issued a Form 483 with five observations after inspecting its Gujarat-based manufacturing plant.

The US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) and a GMP inspection at the company's manufacturing facility in Indrad, Gujarat, from June 3 to June 12, the drug firm said in a regulatory filing.

Also Read | SSC CHSL Exam 2024: Combined Higher Secondary Level Examination To Begin From July 1, Admit Card Likely To Be Released Soon at ssc.gov.in; Know Steps To Download.

At the end of the inspection, the company was issued a Form 483 with five observations, it added.

There is no observation related to data integrity reported, Torrent Pharma said.

Also Read | Andhra Pradesh Cabinet Ministers List 2024: How Many Ministers Are in Andhra Pradesh? Who Is AP Deputy CM? Know Everything Here.

"We will respond to the USFDA within the prescribed time frame and will work in close collaboration with the agency to address the observations at the earliest possible time," it stated.

As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)