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)
You may also be interested in...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.
Beauty Firms Using AI-Based Tools Could Be Subject To Health Privacy Laws In US States
Using AI-based programs to collect and store consumer information risks running afoul of new health privacy laws cropping up in US states. Lack of federal regulation or guidance on the issue is one of the biggest challenges for beauty firms deploying AI, according to Stacy Marcus, partner at Reed Smith LLP.