manufacturing compliance
J&J’s Weldon will appear at next congressional hearing
September 21, 2010Manufacturing and Production Johnson & Johnson, manufacturing compliance, recalls
Johnson & Johnson chief executive William Weldon will appear in person at the next congressional hearing on the company’s wide-ranging …
FDA cites another Sun Pharma unit for GMP violations
September 7, 2010Manufacturing and Production Sun Pharma, manufacturing compliance
Sun Pharmaceuticals’ manufacturing operations have been found wanting by FDA for the second time in recent months, once again for …
Hyaluron pulled up over particle contamination
August 31, 2010Manufacturing and Production Hyaluron, manufacturing compliance
US manufacturer Hyaluron has been sent a warning letter by the FDA after a routine inspection uncovered concerns with aseptic …
Gilead is latest drugmaker in FDA’s sights
August 13, 2010Manufacturing and Production Gilead, cystic fibrosis, manufacturing compliance
A manufacturing and distribution facility operated by US biotech Gilead Sciences is at risk of receiving a warning letter from …
Genzyme posts loss after inventory write-off
August 12, 2010Manufacturing and Production, Sales and Marketing Genzyme, manufacturing compliance
Genzyme has had to write off an additional tranche of product that does not meet quality standards, forcing it to …
Sanofi plant in France under FDA scrutiny
August 3, 2010Manufacturing and Production Sanofi Pasteur, manufacturing compliance
Sanofi-Aventis failed to follow proper quality control procedures at a vaccine manufacturing plant in France, according to the US Food …
Bill would give FDA mandatory recall powers
July 27, 2010Manufacturing and Production FDA, manufacturing compliance, recalls
The chairman of the US congressional committee investigating the quality control problems at Johnson & Johnson, Edolphus Towns, has introduced …
J&J cited by FDA for another manufacturing facility
July 20, 2010Manufacturing and Production J&J, JJ, manufacturing compliance
Another week, another raft of bad news for Johnson & Johnson’s manufacturing division. With one production facility already shut down …
Excipient problem leads to Coumadin recall
July 20, 2010Manufacturing and Production BMS, manufacturing compliance, recalls
Bristol-Myers Squibb is recalling nearly 150,000 tablets of its anticoagulant product Coumadin distributed across the US because some of them …
EMA panel advises Fabrazyme switch
July 7, 2010Manufacturing and Production Fabrazyme, Genzyme, manufacturing compliance
Doctors in Europe have been told they should consider switching patients with Fabry disease away from treatment with Genzyme’s Fabrazyme …
More woe for Genzyme as shipping delays continue
July 6, 2010Manufacturing and Production Cerezyme, Fabrazyme, Gaucher, Genzyme, manufacturing compliance
Genzyme is expecting further delays in shipments of two key products as it struggles to bring its troubled Allston Landing …
CSL vaccine plant cited in FDA letter
July 1, 2010Manufacturing and Production CSL, GMP, P&G, manufacturing compliance
CSL Biotherapies has been sent a letter by the US Food and Drug Administration which indicates that vials of seasonal …
J&J recall plant will be closed all year
June 29, 2010Manufacturing and Production Johnson & Johnson, McNeil, manufacturing compliance
The manufacturing facility at the centre of Johnson & Johnson’s product recall woes is likely to stay closed until at …
Congress summons J&J chief executive
June 23, 2010Manufacturing and Production Johnson & Johnson, McNeil, manufacturing compliance
The Congressional committee looking into the recalls ordered by Johnson & Johnson unit McNeil Consumer Healthcare is planning to hold …
Depomed pulls diabetes drug Glumetza
June 21, 2010Manufacturing and Production Depomed, Glumetza, manufacturing compliance
Another pharmaceutical manufacturer has been forced to recall products because of contamination caused by a chemical used to treat wooden …
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