Earlier this month, Customed, Inc. initiated the largest medical device recall ever recorded in FDA history. The recall was of sterile convenience surgical packs and was due to packaging flaws. These flaws could result in loss of sterility and lead to infection. There have also been a number of voluntary recalls on the drug side related to sterility. FDA has also issued warning letters to pharmaceutical companies for poor aseptic practices, among other Good Manufacturing Practices (cGMP) related issues. These headlines should remind the medical device and pharmaceutical ...
Blog Editors
Recent Updates
- Podcast: Key Changes in Finalized Antitrust Merger Guidelines – Diagnosing Health Care
- FDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements
- Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams
- Importance of Negotiating Assignment and Subletting Provisions in Health Care Leases
- Kentucky Law to Expand Assault in the Third Degree Beyond Healthcare Providers at Hospitals to Include Clinic, Dental, Outpatient Facility Employees, and More