Medtech Insight is part of the Business Intelligence Division 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

Chart: FDA Warning Letters Released the Week of June 1

This article was originally published in The Gray Sheet

Executive Summary

The following chart lists medical-device-related warning letters recently released by FDA. If an inspection led to the warning letter, the location of the inspected facility and dates of inspection are noted; otherwise, the location of the warning letter recipient or website address and date of review is listed. Violations cited by FDA are categorized as follows: quality system regulation (QSR) deficiencies l medical device reporting (MDR) violations l pre-market violations, such as failure to obtain a 510(k) for a device modification or to have a pre-market approval application in effect l failure to submit a corrections and removals report to FDA (C&R) l and unapproved/uncleared/unauthorized products related to H1N1 flu (H1N1 flu)
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT027517

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