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manufacturing compliance

Showing 15 posts of 60 posts found.

J&J’s Weldon will appear at next congressional hearing

September 21, 2010
Manufacturing 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 …

News

FDA cites another Sun Pharma unit for GMP violations

September 7, 2010
Manufacturing 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 …

News

Hyaluron pulled up over particle contamination

August 31, 2010
Manufacturing 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 …

News

Gilead is latest drugmaker in FDA’s sights

August 13, 2010
Manufacturing 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 …

News

Genzyme posts loss after inventory write-off

August 12, 2010
Manufacturing 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 …

News

Sanofi plant in France under FDA scrutiny

August 3, 2010
Manufacturing 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 …

News

Bill would give FDA mandatory recall powers

July 27, 2010
Manufacturing 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 …

News

J&J cited by FDA for another manufacturing facility

July 20, 2010
Manufacturing 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 …

News

Excipient problem leads to Coumadin recall

July 20, 2010
Manufacturing 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 …

News
GenzymeGate

EMA panel advises Fabrazyme switch

July 7, 2010
Manufacturing 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 …

News

More woe for Genzyme as shipping delays continue

July 6, 2010
Manufacturing 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 …

News

CSL vaccine plant cited in FDA letter

July 1, 2010
Manufacturing 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 …

News

J&J recall plant will be closed all year

June 29, 2010
Manufacturing 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 …

News

Congress summons J&J chief executive

June 23, 2010
Manufacturing 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 …

News

Depomed pulls diabetes drug Glumetza

June 21, 2010
Manufacturing 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 …

News
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