The Tricky Business Of Environmental Control
This article was originally published in The Gray Sheet
Executive Summary
From our digital archives: Manufacturers must keep a firm grasp on environmental controls to avoid potentially tough regulatory penalties. “Clearly environmental controls are important, and FDA will and can take major regulatory action when environmental controls aren’t being adhered to,” ex-FDA official Kim Trautman said in September 2011. Communication is cited as an important aspect for firms as they attempt to ensure that facilities meet FDA’s environmental control requirements.
You may also be interested in...
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.
FDA Slaps High Risk Class I Label On Recall Of COVID-19 Diagnostics Made In Uncontrolled Plant
More than 160,000 of the tests were recalled, including 104,900 COVID Test Kits Nonsterile and 61,500 Clean Catch Urine Kits.