Eugia had been cited with four Form 483s at various facilities throughout India since late 2023. In December 2023, the FDA also issued a citation for a plant in New Jersey that Aurobindo said it ...

A Houston-based compounding pharmacy that was recently roped into Eli Lilly’s fight against knockoff GLP-1s has landed in the ...

unveiling a team made up of engineers from the some big U.S. technology firms.He hopes to take over Open AI with this new company. The team at xAI includes Igor Babuschkin, a former engineer at ...

On conclusion of the inspection, the Subsidiary has received One (1) inspectional observation in Form 483. There is no data integrity observation. The Subsidiary will work closely with the USFDA and ...

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...

The United States Food and Drug Administration has inspected Neuland Laboratories Limited's Unit 2 manufacturing facility, ...

One of the key aspects of FDA’s approval of New Drug and Biologic License Applications ... FDA inspections or enforcement letters (e.g., Form 483 observations or Warning Letters) may need ...

Mumbai: Marksans Pharma has announced that the US Food and Drug Administration (USFDA) has concluded an inspection with one ...

The FDA cited deficiencies in the company’s manufacturing processes and quality management systems, as well as shortcomings in its responses to prior Form 483 observations. However, the warning ...

Biomay's recent achievement refers to an inspection by the FDA's Center for Biologics Evaluation and Research (CBER) at ...