Druggmpreport

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June 2019

No. 323

Headlines

Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

WHO Calls for GMPs to Limit Wastewater-Driven Superbugs

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 of good manufacturing practices. Read More

Australia Hikes GMP Clearance Fees

Drugmakers in Australia will soon be subject to higher GMP clearance fees, the Therapeutic Goods Administration (TGA) announced. Read More

Italian Medicines Agency Hits Drugmaker for Major Deficiencies

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. Read More

Canada Details New User Fees for Drug Sponsors

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. Read More

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

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. Read More

Judge 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. Read More

Illinois 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. Read More

Ex-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. Read More

483 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. Read More