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


FDA Eyes Inspectional Form Changes As SOP Troubles Top FDA-483 Citations In 2013

This article was originally published in The Silver Sheet

Executive Summary

The way inspectional observations are presented on FDA-483 forms might be modified under a new FDA pilot program. The goal is to help device companies prioritize corrective actions to avoid potentially serious quality system troubles. The agency decided it was time to reassess how its investigators list observations on the forms after talking with industry device quality experts. The potential change comes at a time when FDA issued a record number of FDA-483s to firms last year, many of which indicated problems with procedures in a variety of quality system areas.

Related Content





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