Trouble

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More bonehead decisions from corporate. This is what project fuel is buying the company.

Hospira recently purchased Javelin.


Trouble before the purchase:

The falling out between the two groups appears to center round issues relating to supply chain problems with Javelin’s lead drug Dyloject in the UK, where sales have been suspended due to regulators finding particles in some vials of the painkiller.

After the purchase:

WASHINGTON, D.C. (TheStreet) -- Two drugs into October's FDA drug approval-palooza, and neither of them makes it across the finish line.

The U.S. Food and Drug Administration also issued a complete response letter for Dyloject, an injectable pain reliever from Hospira(HSP_). "We intend to work with the agency to address the letter. We remain positive about Dyloject’s commercial potential," said Hospira spokesman Daniel Rosenberg, in an email.
 
















































In a nut Shell:

A lengthy Form 483 recently handed to Hospira notes that “products failing to meet established quality control criteria are not rejected.”

An April 4 to 27 FDA inspection of Hospira’s Austin, Texas, plant found it routinely reinspects/reworks “in-process and finished drug products due to defects discovered in-process or post production,” according to the 483.

For example, one of Hospira’s procedures allows for the reinspection or rework of in-process materials, but provides no language “to address in what situations reinspections are appropriate or in what manner to make the determination,” the FDA says.

Hospira’s written procedures are also discussed. The facility does not follow its in-house procedures for the inspection and cleaning of die plates, as the FDA observed an employee performing actions not included in the procedures.

The FDA’s Dallas District Office made a total of 11 observations during its inspection.

“Hospira is committed to the highest standards of product and manufacturing quality,” Hospira spokesman Daniel Rosenberg told DGR.

“We take any observations seriously and appreciate comments from the Agency, as they provide an opportunity to further enhance our quality systems,” Rosenberg said.
 






It's so nice to hear from a fellow Austinite and you must be attached to the Quality group... How's that LEAN thing working out for you; had enough technicians cut yet? After all we just added two hired guns from Freescale for LEAN which means we'll have to cut more folks in Manufacturing and/or Quality to pay for them. Things should be getting better any day now since the exempt re-training beatings, I mean meetings, are starting soon. I can hardly wait; can I be first, can I, please, please??? I wonder how long M2 and DA are going to last; they can't keep beating the crap out of all the underlings as the flight to other companies continues by those who can secure other places of employment....
 
























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