Aurobindo's manufacturing operations have once again landed the Indian drugmaker in hot water with the U.S. FDA. Aurobindo's subsidiary Aurolife Pharma received a Form 483 from the FDA outlining ...

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

In certain circumstances, manufacturers with prior open FDA inspections or enforcement letters (e.g., Form 483 observations or Warning Letters) may need to have these cleared and closed ...

Among the issues detailed in a Form 483 notice issued by the agency was a failure to allow an FDA official access to records generated in the AT-007-1002 clinical trial that was central to the ...

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

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 ...

Laurus Labs has announced that the company has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its API ...

Led by Science 37's internal Quality Assurance & Compliance team, the inspection focused on the company’s role in a registrational Phase 3 asthma study, which Science 37 contributed 28% of the total ...