Dr Reddy's Laboratories received a Form 483 with seven observations from the USFDA for its Srikakulam-based plant in Andhra ...

Emcure Pharma gets two observations for API plant from USFDA “We are addressing the observations comprehensively,” the company said.

API manufacturer Global Calcium has been struck with a Form 483 filing following an FDA inspection of its factory in India.

In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility. As per the USFDA, a ...

In November last year, USFDA had issued Form-483 with eight observations each for product and raw material production centres at Lupin's Mandideep-based manufacturing facility.

At the end of the inspection, we have been issued a 'Form 483' with 1 observation, which is procedural in nature. We will respond to the USFDA within the stipulated timeline and work closely with ...

USFDA issues Form-483 with 1 observation to Torrent Pharma USFDA conducted the pre-approval inspection of the Torrent Pharma Bileshwarpura-based plant from March 13-March 17.

New Delhi, Mar 17 (PTI) Torrent Pharmaceuticals on Friday said the US health regulator has issued Form 483 with one observation after inspecting its Gujarat-based manufacturing facility.

Dr Reddy's Laboratories gets Form 483 from USFDA: This is what it means Dr Reddy's Laboratories has said that its Andhra Pradesh plant got two observations from USFDA.

The FDA injected a Form 483 frown into Revance Therapeutics’ plans to gain regulatory approval for its Botox rival daxibotulinumtoxinA, citing quality control and records issues at the ...

At the conclusion of the inspection of the Bengaluru facility, which took place between January 20-24, 2020, the agency issued a Form 483, with five observations, the filing said.

The FDA has sent a Form 483 to Lupin listing 6 observations its inspectors made during a visit to one of the company's production plants in central India last month. However, the ticking off has ...