manufacturing compliance
J&J expands recall of ‘musty’ products
June 18, 2010Manufacturing and Production Johnson & Johnson, manufacturing compliance
Johnson & Johnson’s manufacturing troubles continues to build with yet another recall announced this week, this time for additional lots …
Study re-opens debate about pharma chemicals in wastewater
June 10, 2010Manufacturing and Production manufacturing, manufacturing compliance
Wastewater from pharmaceutical manufacturing facilities is a major source of drug compounds in the environment, according to a new study …
EMA sees fewer quality defects in ’09 inspections
June 9, 2010Manufacturing and Production API, EMA, manufacturing, manufacturing compliance
The European Medicines Agency carried out 175 inspections of manufacturing facilities in 2009, a little lower than its target, according …
Pfizer recalls Indian-made intravenous drugs
June 7, 2010Manufacturing and Production Claris Lifesciences, Pfizer, manufacturing compliance, recalls
Pfizer is recalling two intravenous antibiotics and an anti-nausea medication after particulate matter was found to be floating in them, leading …
‘Phantom recall’ dogs J&J at congressional hearing
June 1, 2010Manufacturing and Production Johnson & Johnson, McNeil, Tylenol, manufacturing compliance
Johnson & Johnson subsidiary McNeil Consumer Healthcare initiated a recall of its painkiller Motrin (ibuprofen) last year without informing the …
J&J faces FDA scrutiny for another manufacturing unit
May 27, 2010Manufacturing and Production Advanced Sterilization Products, Ethicon, J&J, JJ, McNeil, manufacturing compliance
Another Johnson & Johnson subsidiary has come under scrutiny by FDA for failing to meet quality standards in its manufacturing. …
Genzyme confirms details of consent decree and $175m fine
May 27, 2010Manufacturing and Production Cerezyme, Fabrazyme, Genzyme, Lumizyme, Thyrogen, manufacturing compliance
Genzyme’s predictions on the penalties levied for the ongoing problems at its manufacturing facility in Allston Landing have been confirmed, …
Congress to probe McNeil’s GMP violations
May 7, 2010Manufacturing and Production Johnson & Johnson, McNeil, manufacturing compliance
The US Food and Drug Administration may take additional regulatory action against Johnson & Johnson subsidiary McNeil Consumer Healthcare over …
Congress criticises FDA over contaminated heparin case
May 6, 2010Manufacturing and Production heparin, manufacturing compliance
The US Food and Drug Administration’s follow-up of the contaminated heparin scandal which surfaced in 2008 has been inadequate, according …
More quality issues dog J&J
May 5, 2010Manufacturing and Production Johnson & Johnson, manufacturing compliance, recalls
Johnson & Johnson’s manufacturing is under the spotlight at the FDA once again for quality issues affecting its products. At …
FDA warns Teva over California plant
April 30, 2010Manufacturing and Production Teva, manufacturing compliance
Teva has become the latest drugmaker to be rebuked by the FDA for not responding effectively enough to compliance problems …
Genzyme fined $175m for manufacturing problems
April 22, 2010Manufacturing and Production Cerezyme, Cerezyme Fabrazyme Gaucher's Genzyme, Fabrazyme, Gaucher's, Genzyme, manufacturing compliance
The FDA seems to have lost patience with biotechnology company Genzyme over contamination problems at its manufacturing facilities, levying a …
Third Apotex plant cited in FDA warning letter
April 19, 2010Manufacturing and Production Apotex, generics, manufacturing compliance
Canada’s Apotex has been sent a warning letter citing manufacturing violations at a facility in Toronto that are identical to …
FDA flexes muscles over ailing Genzyme plant
March 29, 2010Manufacturing and Production Cerezyme, Fabrazyme, Gaucher, Genzyme, manufacturing compliance
Manufacturing compliance problems continue to weigh down US biotechnology company Genzyme, with the US Food and Drug Administration now saying …
Virus contamination found in GSK’s Rotarix
March 23, 2010Business Services, Manufacturing and Production, Sales and Marketing Contamination, GSK, Vaccine, manufacturing compliance
The European Medicines Agency has demanded more information “as a matter of urgency” from GlaxoSmithKline over a virus in its …
