Tag:
quality
Latest Headlines
Latest Headlines
Hospira's quality issues weigh on Q4 results, 2012 forecast
The good news for Hospira: Quarterly sales rose 2.2% to more than $1 billion. The not-so-good: The costs of fixing manufacturing problems pushed earnings into the red. The company's net loss amounted
WSJ: Another executive shake-up at J&J's McNeil unit
Johnson & Johnson ( $JNJ ) is taking an eraser to its McNeil Consumer Healthcare org chart again. Less than 12 months after a management shake-up put them in positions crucial to a McNeil
KV crows over Makena purity as FDA checks claim
Tuesday was a good day for beleaguered KV Pharma ( $KV.A ), known recently for its he-said/she-said lawsuits with a former CEO and its exorbitant price setting of preterm-birth preventer Makena after
Accucaps maker describes need for gel-cap manufacturing finesse
"This is an industry that relies on your brains, not your brawn," says ops VP Glen Harron of gel-cap maker Accucaps. "It relies on a very self-disciplined workforce. People need to keep a slow,
FDA details its actions on shortages
A companion to the HHS report on the economics of drug shortages [ see related story ] is an FDA analysis of its role in resolving them. President Barack Obama also mentioned this report in the
HHS details manufacturing role in drug shortages
About 54% of sterile injectable drug shortages are caused by manufacturing quality problems. The U.S. Department of Health and Human Services reports that "some of the largest manufacturers of
'Little things' blossomed into big QA trouble at J&J/McNeil
"When they leave, they take the routine with them," said an anonymous former J&J/McNeil worker of QA staff reductions following the company's acquisition of Pfizer Consumer Healthcare in 2006.
Hospira plant remediation stings company financials
Hospira ( $HSP ) has taken a big financial hit as a result of manufacturing deficiencies at its Rocky Mount, NC, plant. The hit--more than $1 billion in market capitalization, according to the
Quality meltdown still affects J&J financials, though Q3 sales are up
Johnson & Johnson ( $JNJ ) reports today in third-quarter financials that U.S. sales of OTC medicines were "significantly impacted" by the shutdown of McNeil's Consumer Healthcare manufacturing
FDA: Product quality issues fuel rise in drug shortages
"A very large number of quality product issues" is what Valerie Jensen, associate director for FDA's drug shortage program ( CDER ), cites as the major cause of the 178 shortages counted by the
