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manufacturing compliance

Showing 15 posts of 60 posts found.

J&J expands recall of ‘musty’ products

June 18, 2010
Manufacturing 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 …

News

Study re-opens debate about pharma chemicals in wastewater

June 10, 2010
Manufacturing 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 …

News

EMA sees fewer quality defects in ’09 inspections

June 9, 2010
Manufacturing 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 …

News

Pfizer recalls Indian-made intravenous drugs

June 7, 2010
Manufacturing 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 …

News

‘Phantom recall’ dogs J&J at congressional hearing

June 1, 2010
Manufacturing 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 …

News

J&J faces FDA scrutiny for another manufacturing unit

May 27, 2010
Manufacturing 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. …

News

Genzyme confirms details of consent decree and $175m fine

May 27, 2010
Manufacturing 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, …

News

Congress to probe McNeil’s GMP violations

May 7, 2010
Manufacturing 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 …

News

Congress criticises FDA over contaminated heparin case

May 6, 2010
Manufacturing 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 …

News

More quality issues dog J&J

May 5, 2010
Manufacturing 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 …

News

FDA warns Teva over California plant

April 30, 2010
Manufacturing 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 …

News
Genzyme

Genzyme fined $175m for manufacturing problems

April 22, 2010
Manufacturing 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 …

News

Third Apotex plant cited in FDA warning letter

April 19, 2010
Manufacturing 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 …

News

FDA flexes muscles over ailing Genzyme plant

March 29, 2010
Manufacturing 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 …

News

Virus contamination found in GSK’s Rotarix

March 23, 2010
Business 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 …

News
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