Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Compliance 360° Part 5: Medical Device 483s – US FDA's Top 5 Observations

Executive Summary

This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fifth installment, former FDA investigations branch director Ricki Chase highlights the agency's top 5 inspection observations found on FDA-483 inspection forms, including failing to have procedures for corrective and preventive action (CAPA), complaint handling, purchasing controls, process validation, and nonconforming product.

When it comes to the top flubs made by medical device manufacturers, it's all about procedures.

Specifically, firms fail to have procedures for corrective and preventive action (CAPA), complaint handling, purchasing controls, process validation, and nonconforming product, Ricki Chase says in the fifth installment of Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues.

In the podcast, Chase – a former FDA investigations branch director – highlights those top 5 inspection observations, which are found on most FDA-483 forms following a facility inspection.

"In my opinion, a solid quality system begins with having a skilled quality team, [and] clear, concise and validated procedures prepared by cross-functional teams; strong employee training, and ownership of their very important role in each step of the process. And, a corporate culture which supports identification and correction of quality problems, continuous improvement, and leadership responsibility," she said.

Chase is compliance practice director for Lachman Consultant Services, a firm she joined in June 2016 after spending 16 years at FDA, where she was also an investigator, medical device specialist and supervisory investigator.

Listen to the podcast via the player below:

 

Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

MT104529

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel