Tag:
FDA 483
Latest Headlines
Latest Headlines
Hospira recalls sodium chloride after copper particles found
Hospira has issued another recall of a product from its key sterile injectables plant. Problems there and at other plants have been a gift to competitors who are boosting sales of products that Hospira has had trouble getting to market.
UPDATED: Claris says it satisfied FDA in plant inspection, awaits final word
After two years of having products blocked by the FDA, Claris Lifesciences says it has passed an audit and is awaiting word on whether it will again be able to ship to the U.S.
Novartis remediation drags on longer than expected
In reporting an 8% first-quarter earnings decline to shareholders, Novartis acknowledged the company's inability to meet GMPs at a variety of plants played a big role in that dip.
Hospira sees dim light at end of plant troubles
Executives see the light at the end of the tunnel where Hospira's ( $HSP ) manufacturing stumbles are concerned, but that light appears to be from a 60-watt bulb where a 100-watt is needed. Mike...
FDA: Novartis plant shows patterns of problems
Health Canada on Friday advised Canadians that they should return certain Excedrin Extra Strength and Tension Headache caplets, just as drug giant Novartis ( $NVS ) advised U.S. consumers to do last
Stability skimping a frequent component in FDA warnings
WOBURN, MA--Behind every drug expiration date is stability testing and, it is hoped, a stabilitarian--one who coordinates the functions that contribute to determining drug stability. "Stability is a
Rockline quietly recalls contaminated wipes
Contaminated wipes are making headlines again, but this time the hot seat is occupied by Wisconsin-based Rockline Industries. The company's baby wipes recall marks its fifth in a decade, occurring in
J&J releases Doxil batch; Ben Venue troubles detailed in FDA report
An in-process batch of cancer drug Doxil, halted at Ben Venue Labs when the contract manufacturer suspended operations due to QA concerns, has cleared the scrutiny of Johnson & Johnson ( $JNJ ) and
Genentech, INIS demonstrate art of FDA response
Genentech and International Isotopes ( $INIS ) appear to be setting casebook examples of how to respond to the FDA over GMP concerns. Both companies filed responses to the agency within the allotted
International Isotopes gets FDA warning
The FDA has cited International Isotopes ($INIS) for 6 GMP violations in Warning Letter SEA 12-03, issued Oct. 26 and just posted to the agency's website. The Idaho Falls, ID-based company supplies
