Cipla's manufacturing facility in Goa gets two observations in Form 483 from US FDA

Cipla said that the United States Food and Drug Administration (US FDA) has conducted an inspection at the company's manufacturing facility in Verna, Goa, India from 6th to 17th April 2026.

Lupin's New Jersey-based facility gets Form-483 with three observations from US FDA

Lupin said that the United States Food and Drug Administration (U.S. FDA) has concluded an inspection at our manufacturing facility located in Somerset, New Jersey, U.S.A.
RAPS

New FDA Warning Letter, Form 483 for Two Indian Companies

The US Food and Drug Administration (FDA) in April warned Indian active pharmaceutical ingredient (API) maker Sal Pharma and handed an inspection report with six observations to major generic ...
Nasdaq

Integra LifeSciences reports FDA warning letter related to quality system issues

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...
RAPS

'Questionable' Documentation Practices Lead FDA to Issue Form 483 to Biogen Idec

The US Food and Drug Administration (FDA) has released the text of a Form 483 sent to biopharmaceutical manufacturer Biogen Idec, outlining a series of alleged deficiencies affecting the manufacture ...
FiercePharma

Under FDA scrutiny, Aurobindo's Eugia tallies a 5th Form 483 in less than a year

Eugia remains under FDA scrutiny as the unit of Indian drugmaker Aurobindo has received its fifth Form 483 since December. The company’s latest slap from the U.S. regulator stems from an April 25 to ...
PharmTech

Novo Nordisk Leaders on the Future of Pharma QMS

Andrew Chang and Steven Falcone, Novo Nordisk, discuss GMP mutual recognition, real-time digital monitoring, and the future ...