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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