Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September.

FDA's rising criticism: A response option

With an expanded staff and power, FDA 483 letters are expected to rise. Here's one option on how to avoid and respond to agency criticism.

Hp 19185 I Stock Warning And Risk

CEE Packaging, the Packaging Industry of Central and Eastern Europe, reports that a 10-step guide is available to help pharmaceutical processors, medical device manufacturers, and other life-sciences facilities respond appropriately within the permitted 15-day window of receiving a 483 letter from the agency. The guide, “How to Avoid and Respond to Public FDA Criticisms—Form 483 Letters—for Temperature, Humidity and other Controlled Environments,” comes from Veriteq.

CGMP.com provides some basics on FDA-issued warning letters.

Packaging World/Healthcare Packaging legal columnist Eric Greenberg recently discussed the agency's increasing activity. Read more about FDA, regulatory, and legal developments.

-Jim Butschli, Editor

Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences