Tag:
FDA inspection
Latest Headlines
Latest Headlines
FDA inspectors cite problems at Impax California plant
A small California drugmaker that in January said it was licensing a migraine drug from AstraZeneca ($AZN) is having manufacturing issues that are causing headaches of their own.
FDA in line for new foreign-inspection powers
The latest version of the Prescription Drug User Fee Act, which is nearing passage in Congress, would give the FDA new powers to police imported drug ingredients and inspect overseas facilities, and drugmakers would face new requirements for reporting production problems that might lead to shortages.
FDA says APP ignored consumer complaints for 18 months
New details about problems with the production of heparin and other drugs by APP Pharmaceuticals ( $APPX ) have been released by the Food and Drug Administration on its website.
Integra collagen plant fights mold
Integra LifeSciences, which manufacturers medical devices used in surgery, has been fighting a mold problem at its collagen manufacturing facility in Plainsboro, NJ, for more than two years, the FDA...
Congresswoman: Novartis troubles call for more FDA oversight
California Congresswoman Mary Bono Mack said she is perplexed that FDA inspectors continued to cite problems at the Novartis ( $NVS ) Lincoln, NE, plant without holding the drugmaker accountable. The...
FDA: Novartis plant shows patterns of problems
Health Canada on Friday advised Canadians that they should return certain Excedrin Extra Strength and Tension Headache caplets, just as drug giant Novartis ( $NVS ) advised U.S. consumers to do last
J&J releases Doxil batch; Ben Venue troubles detailed in FDA report
An in-process batch of cancer drug Doxil, halted at Ben Venue Labs when the contract manufacturer suspended operations due to QA concerns, has cleared the scrutiny of Johnson & Johnson ( $JNJ ) and
Ben Venue shutdown strains J&J drug supply
The Ben Venue unit of Boehringer Ingelheim has temporarily suspended drug manufacture and distribution at its Bedford, OH, facility. The voluntary action is expected to further strain supplies of
UPDATED: FDA visits Indian plant after meningitis outbreak
The drug regulator for Maharashtra has inspected the east Indian manufacturing plant of Ciron Pharmaceuticals, supplier of the anesthetic bupivacaine to hospitals, following the appearance of 11
Plant check reveals Genentech report flaw repeat
Roche unit Genentech has been called on manufacturing anomalies following an inspection of the California plant where it makes Avastin . Particle contamination and disintegrating gaskets were part of
