At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility
The inspection concluded with zero Form 483 observations
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA
This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence
The FDA issued Form 483 with one observation related to building and facility management
These observations are procedural in nature and none of them are related to data integrity
The Subsidiary has received one inspectional observation in Form 483
Subscribe To Our Newsletter & Stay Updated
