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)