FDA’s FY 2015 Drug GMP Warning Letters
This article was originally published in The Gold Sheet
Executive Summary
Descriptions follow of all 42 drug GMP warning letters of fiscal year 2015, listed by type of drug product involved. See who they went to, when they were sent and what they were about.
You may also be interested in...
Outsourcing Pharmacy Asks Court To Restrain FDA From Shutting It Down Over Contamination
A Little Rock, Arkansas, outsourcing pharmacy continued to defy FDA even after the agency went to court for an injunction to shut down the pharmacy's drug compounding operations over continued lack of sterility. Cantrell Drug Co. could have accepted proposed consent decree terms but instead countered in federal bankruptcy court with an injunction request of its own.
FDA GMP Warning Letters Review: Rate Soared In 2016 On Sterility And Data Integrity Concerns
Poor data integrity at Asian API firms, poor quality programs at foreign OTC firms and poor sterility assurance at US compounding pharmacies were the main factors leading US FDA to issue 110 drug GMP warning letters in 2016, a huge increase from prior years. Article is first of four-part series in our annual analysis.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.