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Health Canada Issues Final Guidance on 3D-Printed Implantable Devices

  • Post author:Sam
  • Post published:June 7, 2019
  • Post category:The GMP Letter

Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Source: The GMP Letter

Continue ReadingHealth Canada Issues Final Guidance on 3D-Printed Implantable Devices

483 Roundup: FDA Cites Five Firms for Quality, Other Violations

  • Post author:Sam
  • Post published:June 4, 2019
  • Post category:Drug GMP Report

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

Continue Reading483 Roundup: FDA Cites Five Firms for Quality, Other Violations

Ex-FDA Investigator Blows Whistle on FDA’s Handling of Foreign Inspections

  • Post author:Sam
  • Post published:June 4, 2019
  • Post category:Drug GMP Report

The FDA is struggling to keep inspections of facilities overseas up to par, according to a former agency investigator. Source: Drug GMP Report

Continue ReadingEx-FDA Investigator Blows Whistle on FDA’s Handling of Foreign Inspections

Illinois Compounder Hit With Consent Decree Over Violations at Multiple Sites

  • Post author:Sam
  • Post published:June 4, 2019
  • Post category:Drug GMP Report

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

Continue ReadingIllinois Compounder Hit With Consent Decree Over Violations at Multiple Sites

Judge Enters Consent Decree Against Texas Compounder

  • Post author:Sam
  • Post published:June 4, 2019
  • Post category:Drug GMP Report

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

Continue ReadingJudge Enters Consent Decree Against Texas Compounder

Warning Letter Roundup: FDA Warns Five Firms for Quality, GMPs

  • Post author:Sam
  • Post published:June 4, 2019
  • Post category:Drug GMP Report

The FDA issued warnings to one Indian drugmaker, one Canadian manufacturer and four U.S. facilities for a variety of violations including falsified or missing data. Source: Drug GMP Report

Continue ReadingWarning Letter Roundup: FDA Warns Five Firms for Quality, GMPs

Canada Details New User Fees for Drug Sponsors

  • Post author:Sam
  • Post published:June 4, 2019
  • Post category:Drug GMP Report

Health Canada is increasing fees for drug sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. Source: Drug GMP Report

Continue ReadingCanada Details New User Fees for Drug Sponsors

Italian Medicines Agency Hits Drugmaker for Major Deficiencies

  • Post author:Sam
  • Post published:June 4, 2019
  • Post category:Drug GMP Report

Italian regulators suspended a drugmaker’s marketing authorization following an inspection that revealed serious quality violations at its facility in Cellole—about 30 miles northwest of Naples. Source: Drug GMP Report

Continue ReadingItalian Medicines Agency Hits Drugmaker for Major Deficiencies

WHO Calls for GMPs to Limit Wastewater-Driven Superbugs

  • Post author:Sam
  • Post published:June 4, 2019
  • Post category:Drug GMP Report

The World Health Organization released draft guidelines advising regulators to test the wastewater of drug plants to keep antibiotics out of the environment—and it says wastewater treatment should be part…

Continue ReadingWHO Calls for GMPs to Limit Wastewater-Driven Superbugs

Italian Medicines Agency Nails Drugmaker for Major Deficiencies

  • Post author:Sam
  • Post published:May 29, 2019
  • Post category:Drug Industry Daily

Italian regulators suspended a drugmaker’s marketing authorization following an inspection that revealed multiple serious quality violations at its facility in Cellole—about 30 miles northwest of Naples. Source: Drug Industry Daily

Continue ReadingItalian Medicines Agency Nails Drugmaker for Major Deficiencies
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