Posts tagged good manufacturing practices.
Blogs
2 minute read
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
- Important Negotiating Points in Commercial Real Estate Purchase and Sale Contracts Negotiating the Letter of Intent
- 2025 Picks Up Steam with Increased Scrutiny of Health Care Transactions and Corporate Structures
- HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking
- Sitting Atop a Telehealth Cliff?
- A Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule