FDA Form 483: The Right Response

What happens if you receive an FDA Form 483? What if it is followed up with a Warning Letter?

Receiving an FDA 483 Inspectional Observation and/or a Warning Letter can be a surprising and stressful occurrence. In this session, Jared Pappas, from The Eye Bank of Kentucky, and Jerry Burkey, from the San Diego Eye Bank, briefly outline some reasons for receiving a Form 483 and/or a warning letter, but more importantly how to respond in a constructive, respectful way.

Participants will learn:

What a Form 483 is
Why a Form 483 or Warning Letter may be received
How to prepare a meaningful response
The importance of having the right perspective

Join this informative webinar to find out what to do if you receive an FDA Form 483. Learn how to respond rather than react!

Jerry Burkey, CEBT

Quality Assurance Lead

San Diego Eye Bank

Jerry Burkey, CEBT, is a Certified Eye Bank Technician and the Quality Assurance Lead at the San Diego Eye Bank. Prior to working in Eye Banking, Jerry was a Fire Chaplain and Executive Director at FirefighterAid. He has 15 years of experience in eye banking across various disciplines, having worked in Recovery, Quality, Hospital Development, and Donor Eligibility. Jerry currently serves on the EBAA QA Committee and the Technical Procedures Manual Subcommittee.

Kip Hoffman, CQT (ASQ)

Quality Coordinator

Iowa Lions Eye Bank

Kip Hoffman, CQT (ASQ), is the Quality and Compliance Coordinator at Iowa Lions Eye Bank and the Chair of the EBAA Quality Assurance Committee. He cares for audits, document control, compliance, data analysis and the like, having prior experience working with quality and purchasing in the manufacturing sector. He is an ASQ Certified Quality Technician and specializes in SOP creation and Lean concept.

Jared Pappas

Interim Director, Clinical Services

The Eye Bank of Kentucky

Jared Pappas is the Interim Director, Clinical Services at The Eye Bank of Kentucky. Jared has over 10 years of experience in Quality Assurance and Regulatory Affairs in both eye banking and medical devices where his responsibilities encompassed EBAA and ISO accreditations/certifications, FDA 510k and PMA submissions, IDE clinical trials, quality audits and SOPs. Jared currently serves on the EBAA QA Committee.