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 |
|
Discussion of Examples |
Jennifer DelValleOrtiz, MS |
|
Q&A Discussion Panel |
Rebecca Asente and Jennifer DelValleOrtiz |
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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
- FDA Form 483 Frequently Asked Questions
- Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry
- Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry
- Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice | FDA
- Human Drug Compounding
- Compounding Quality Center of Excellence | Training Programs
- FDA Inspections of Outsourcing Facilities (webinar)
- Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter (webinar)
Event Materials
| Title | File Type/Size |
|---|---|
| FDA Compounding Quality Center of Excellence_What to Expect After an Inspection | pdf (415.04 KB) |