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

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

Timestamps

07:07 – Rebecca Asente, MS, RD - What to Expect After an Inspection

31:02 – Jennifer DelValleOrtiz, MS - Discussion of Examples

42:58 – Q&A Discussion Panel

59:16 – FDA Compounding Quality Center of Excellence

Speakers:

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

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

Jill Hammond
Captain, US Public Health Service
Program Manager
Office of Compounding Quality & Compliance (OCQC)
Office of Compliance (OC)
Center for Drug Evaluation and Research (CDER)| US FDA

Panelists:
Rebecca Asente and Jennifer DelValleOrtiz

Learn more at: https://www.fda.gov/drugs/news-events...

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