U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. What to Expect after an Inspection: 483s, Responses and Beyond - 12/14/2022
  1. News & Events for Human Drugs

Virtual | Virtual

Event Title
What to Expect after an Inspection: 483s, Responses and Beyond
December 14, 2022


Date:
December 14, 2022
Time:
2:00 PM - 3:00 PM ET

 

Topic & Presentations

Speakers

What to Expect after an Inspection: 483s, Responses and Beyond

 

What to Expect After an Inspection

Rebecca Asente, MS, RD
Compliance Officer
Office of Pharmaceutical Quality Operations (OPQO)
Office of Regulatory Affairs (ORA) | US FDA

Discussion of Examples

Jennifer DelValleOrtiz, MS
Supervisory Consumer Safety Officer
Division of Compounding I (DC1)
Office of Compounding Quality & Compliance (OCQC)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | US FDA

Q&A Discussion Panel

Rebecca Asente and Jennifer DelValleOrtiz

 

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

During this webinar, FDA will provide an overview of what to expect after a compounding inspection. FDA will discuss the intent of an FDA Form 483, ‘Inspectional Observation,’ compounding inspection closeout meetings, post-inspection expectations and regulatory responses, and provide a few examples to help explain how best to respond to an FDA Form 483 observation after a compounding inspection.

If an FDA investigator observes potential violations of the Food Drug and Cosmetic (FD&C) Act and its implementing regulations during an inspection, then an FDA Form 483 is issued to the most responsible person at a firm at the conclusion of the inspection. The FDA Form 483 does not constitute a final agency determination and firms are encouraged to respond to the FDA Form 483 in writing with their corrective action plan with supporting documentation within 15 business days from the issuance of the FDA Form 483 and implement the corrective action plan expeditiously.

TOPICS COVERED

  • FDA Form 483
  • Compounding Inspection Closeout Meetings
  • FDA Form 483 Responses for Compounding Inspections
  • Post-Inspection Expectations
  • FDA Form 483 Examples and Regulatory Responses for Compounding Inspections

INTENDED AUDIENCE

  • Compounding Outsourcing Facilities
  • Compounding pharmacies with interest in the outsourcing facility sector and FDA compounding inspections
  • State pharmacy regulators
  • Consultants focused on outsourcing facilities and compounding pharmacies
  • FDA-regulated industry or general public with an interest in the inspections process for compounding pharmacies and outsourcing facilities

FDA SPEAKERS

Jennifer DelValleOrtiz, MS
Supervisory Consumer Safety Officer
Division of Compounding I (DC1)
Office of Compounding Quality & Compliance (OCQC)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER) | US FDA

Rebecca Asente, MS, RD
Compliance Officer
Office of Pharmaceutical Quality Operations (OPQO)
Office of Regulatory Affairs (ORA) | US FDA

FDA RESOURCES


Event Materials

 
Back to Top