Tag:
GMP inspections
Latest Headlines
Latest Headlines
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
KV reports doubt about viability under decree
KV Pharmaceuticals ( $KV.A ) has "substantial doubt" about its ability to "continue as a going concern," according to a financial statement filed last week. In the Form 10-Q, the troubled drugmaker
Genentech, INIS demonstrate art of FDA response
Genentech and International Isotopes ( $INIS ) appear to be setting casebook examples of how to respond to the FDA over GMP concerns. Both companies filed responses to the agency within the allotted
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
Ben Venue inspection yields 48 GMP violations
By FDA inspection report standards, the length of the document alone suggests the magnitude of the quality and manufacturing compliance issues at Ben Venue , an arm of Boehringer Ingelheim . The 33
Pharmetics recalls pain relievers in Canada
Health Canada announced Tuesday that OTC drugmaker Pharmetics is recalling six pain-relief products. The recall follows a GMP inspection by the regulator of the contract manufacturer's plant in
FDA impatience shows in Apotex warning letter
The ticking noise that Apotex President and COO Jack Kay has been hearing is the FDA's 15-day response clock running down after the drugmaker received Warning Letter 320-10-003. The letter cites
Ranbaxy teeters on Caraco-ism
The recent FDA warning letter to Ohm Laboratories, in which the regulator calls "inadequate" the company's corrective measures to fix GMP violations, has left the company in a precarious position.
Pilot to streamline international inspections
The European Directorate for the Quality of Medicines has established bilateral confidentiality agreements with the U.S. FDA and the Australian Therapeutic Goods Administration to share information
