A Form 483 is issued at the conclusion of an inspection when USFDA investigators observe conditions that may be in violation ...

Dr Reddy's Laboratories Ltd.'s formulations manufacturing facility was given "Form 483" with seven observations from the ...

The U.S. FDA inspected Lupin's Pithampur Unit-2 manufacturing facility from July 08 to July 17, 2025. The inspection closed with the issuance of a Form-483 with four observations.

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

Emcure Pharma share price rose in trade after the company announced that United States Food and Drug Administration (USFDA) ...

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Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...

Gland Pharma’s facility in Visakhapatnam, which was earlier this year issued Form 483 with three observations by the U.S. Food and Drug Administration, has since received an establishment ...

Granules India's subsidiary resolves FDA observation during inspection at Virginia facility, parent company confirms in filing.

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 ...

The reason the Knoxville campus has fewer buildings on the University of Tennessee System's priority list is twofold. One has ...

The new accreditor will be called the Commission for Public Higher Education, and the University of North Carolina System is ...