Archive for June 2019
Phototherapy Developer Amiss on CAPA, Supplier Audits
Phototherapy developer National Biological Corp. fell short on several quality management systems, the FDA said following a Feb. 4-14 inspection of its Beachwood, Ohio plant. Source: The GMP Letter
Read MoreSingapore Diagnostics Maker Fails to Establish SOPs for Investigations
Failure to establish standard operating procedures for investigations landed Singapore-based diagnostics maker MP Biomedicals Asia Pacific in hot water with the FDA following a Dec. 10-12, 2018 inspection of its Singapore facility. Source: The GMP Letter
Read MoreSloppy Validation, Complaint Handling Found at Duke Empirical
Process validation issues and failure to document complaints and corrective and preventive actions landed devicemaker Duke Empirical an FDA Form 483 following a Dec. 3-21, 2018, inspection of its Santa Cruz, California plant. Source: The GMP Letter
Read MoreWarning Letter Roundup: FDA Flags Four Firms for Quality
The FDA issued warning letters to devicemakers in Michigan, Nevada, Idaho and Texas for numerous quality failures. Source: The GMP Letter
Read MoreEuropean Commission Clarifies What UDI Info Is Needed for Eudamed
The European Commission released new details on what datasets devicemakers should include in the Eudamed database for unique device identifiers under the new Medical Device Regulation and In Vitro Diagnostic Regulation. Source: The GMP Letter
Read MoreHealth Canada Issues Final Guidance on 3D-Printed Implantable Devices
Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Source: The GMP Letter
Read More483 Roundup: FDA Cites Five Firms for Quality, Other Violations
The FDA flagged four U.S. facilities and one in Switzerland for quality and other violations observed during agency inspections—from inadequate testing to incomplete records. Source: Drug GMP Report
Read MoreEx-FDA Investigator Blows Whistle on FDA’s Handling of Foreign Inspections
The FDA is struggling to keep inspections of facilities overseas up to par, according to a former agency investigator. Source: Drug GMP Report
Read MoreIllinois Compounder Hit With Consent Decree Over Violations at Multiple Sites
Illinois-based compounder PharMedium Services has been ordered to shut down operations at its Tennessee site after repeated warnings from the FDA to clean up its act. Source: Drug GMP Report
Read MoreJudge Enters Consent Decree Against Texas Compounder
A federal judge has ordered a Texas drug compounder to cease all operations after failing to respond to warnings from the FDA about insanitary conditions. Source: Drug GMP Report
Read More