AM2PAT-five dead

[underpants]

FDA defends its oversight of syringe firm
March 30, 2009
http://www.wral.com/news/local/story/4844126/

Syringes from AM2PAT were taken off the market early last year and the Angier plant was closed following an outbreak of the bacterial infection Serratia in Colorado, Texas, Illinois and Florida. Five people died of the infection, and at least 100 others were sickened.

"It shocked me. I'm not so sure it's still sunk in all the way," he said.

Two AM2PAT managers pleaded guilty last month to federal fraud charges, and authorities are searching for company's President Dushyant Patel. Prosecutors said AM2PAT officials operated a filthy "clean room" inside a former motorcycle plant and falsified safety records to make it appear as though the proper checks were in place before syringes were shipped.

Months after the plant closed, syringes and papers – one was a document on how to make a clean room – remain strewn about inside, and containers of Heparin still stack shelves.

"(It was a) sweatshop, bottom line," Martin said.


Syringe whistleblower warned FDA
Updated: Wednesday, 25 Mar 2009, 4:47 PM EDT
Published : Wednesday, 25 Mar 2009, 4:45 PM EDT

http://www.wthitv.com/dpp/healthy_living/general_health/wwlp_ap_health_syringewhistleblowerwarnedfda_2009032516412278496


RALEIGH, N.C. (AP) - Several months before federal investigators linked a North Carolina syringe manufacturer to hundreds of illnesses and five deaths, a whistleblower wrote to regulators to warn about the poor conditions inside a room vital to producing a sterile product.

U.S. Food and Drug Administration records released Friday to The Associated Press through a Freedom of Information Act request show no sign that inspectors tried to address the concerns of the AM2PAT Inc. employee. She told the agency in a June 2007 e-mail, months before the outbreak was discovered, the firm was not operating appropriate temperatures in its cleanroom -- an environmentally controlled site where air is constantly monitored.

Federal investigators believe a rush to maximize profits led the company to produce heparin and saline syringes that sickened hundreds, resulting in spinal meningitis and permanent brain damage for some.

Prison time handed out in AM2PAT, Sierra Pre-Filled syringe scandal
Monday, February 23, 2009
http://www.bizjournals.com/triangle/stories/2009/02/23/daily15.html

Two former employees of AM2PAT Inc. were sentenced Monday in Raleigh to 54 months in prison for their roles in sending out improperly labeled syringes linked to hundreds of bacterial infections and some deaths, according to a statement issued by U.S. Attorney George E.B. Holding.

U.S. District Judge Terrence Boyle handed down the sentences against Ravindra Kumar Sharma, 54, of Richmond, Va., and Aniruddha Patel, 43, of Carpentersville, Ill. The two men pleaded guilty to a number of federal charges, among them mail fraud and knowingly sending misbranded medical devices into interstate commerce with the intent to defraud.

[valerief]

1. Inspectors are supposed in inspect? Not in pig-greedy capitalist America!

<<U.S. Food and Drug Administration records released Friday to The Associated Press through a Freedom of Information Act request show no sign that inspectors tried to address the concerns of the AM2PAT Inc. employee. >>

[underpants]

2. USDA medical device administration has the same staff level as 15 years ago

I read this in a "News of the Weird" section of a free mailer and looked up AM2PAT-can't find the part about the USDA net hires

Still inspectors should actually visit the site regardless of how understaffed they are