Tag:
inspection
Latest Headlines
Latest Headlines
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
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
Rx-360 launch reinforces benefits of shared audits
The drug quality and authenticity nonprofit Rx-360 has launched its audit sharing program, through which members collect and share details of their findings from suppliers' investigations. Members
Government, generic industry reach agreement on fees
After many years of negotiations with the U.S. government, the generic drug industry has agreed to pay $299 million in annual fees to allow for inspections of foreign manufacturing plants every two
Will Ranbaxy plant clear FDA inspection?
The FDA has started its inspection of a Ranbaxy Laboratories plant in India--a move that could help the generics maker resume supplies to the U.S. market after nearly three years under an import
FDA: Overseas manufacturing puts U.S. at risk
So many of the drugs approved in the U.S. are manufactured overseas that the FDA is having a hard time keeping up with inspections in the supply chain. The result could be another tainted-drug
India considers drug-inspector job requirements
A high court in India has provisionally ruled that petitioning candidates for the post of drug inspector may interview. Kuldeep Singh and 17 others asked the court to overturn a list of strict
FDA to contract out more foreign inspections
Big Pharma has been riding the outsourcing wave for years now. Why not the FDA? The agency says it's looking to farm out more inspections of foreign plants, as it aims to expand oversight in the
FDA needs to refocus plant inspections, GAO says
The federal government watchdog says the FDA has its inspection priorities out of whack. The Government Accountability Office took a look at the agency's inspection records and decided the FDA still
