InvaGen Pharmaceuticals Interview Questions and Answers

I have faced 3 FDA audits in my career.

• I have faced 3 FDA audits in my career.

• I have experience in preparing for and participating in FDA audits.

• I am familiar with FDA regulations and guidelines.

• I have successfully addressed any findings or observations from previous FDA audits.

• I have worked with cross-functional teams to ensure compliance with FDA requirements.

Form 483 is a document issued by the FDA to notify a company of observed deviations from current Good Manufacturing Practices (cGMP).

• Form 483 is issued after an FDA audit or inspection of a facility.

• It lists the observations made by the FDA investigator regarding non-compliance with cGMP regulations.

• The observations may include issues related to manufacturing processes, quality control, documentation, or facility maint...read more