FDA Follows Up Shelhigh Seizure With Formal Request For Recall
This article was originally published in The Gray Sheet
Executive Summary
FDA is leaning on tissue product manufacturer Shelhigh to recall its entire product line after all inventory at its manufacturing facility was seized by federal marshals last month
You may also be interested in...
Shelhigh Signs Consent Order Suspending Distribution Of All Products
Tissue product manufacturer Shelhigh signed a court order on June 22 agreeing to stop distributing its entire product line until the company brings its production process in line with FDA standards
Shelhigh Signs Consent Order Suspending Distribution Of All Products
Tissue product manufacturer Shelhigh signed a court order on June 22 agreeing to stop distributing its entire product line until the company brings its production process in line with FDA standards
FDA Seizes Tissue Valve Firm’s Entire Product Line, Citing Sterilization Issues
U.S. marshals confiscated all devices manufactured by New Jersey-based Shelhigh in an April 17 seizure resulting from FDA concerns with product sterility