Regulatory Affairs Certification (RAC) Practice Exam

What document is discussed during a meeting after a deficiency is noted in a Preapproval Inspection?

1. Form FDA 483

2. Investigational New Drug Application

3. New Drug Application

4. Product recall notice

The correct answer is: Form FDA 483

The Form FDA 483 is the correct document discussed during a meeting after a deficiency is noted in a Preapproval Inspection. This form is issued by the Food and Drug Administration (FDA) to provide a summary of significant deficiencies observed during the inspection. It serves as a communication tool between the FDA and the inspected entity, highlighting any issues that must be addressed before the approval of a new drug or biologic can proceed. The significance of the Form FDA 483 lies in its role in regulatory compliance; it lists observations that may potentially violate Good Manufacturing Practice (GMP) regulations. After the issuance of a Form FDA 483, the company involved is expected to respond with corrective actions and a plan to rectify the noted deficiencies. This discussion is critical for ensuring that any compliance issues are resolved and does not delay the drug approval process. Investigational New Drug Applications and New Drug Applications are key documents in the drug approval process but are not specifically focused on deficiencies noted during inspections. A product recall notice pertains to actions taken after a product has been approved and is on the market, addressing safety issues rather than deficiencies found during inspections. Thus, these documents do not fit the context of a meeting initiated due to inspection findings.