Questions Raised About FDA Handling of Triad Problems

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Questions Raised About FDA Handling of Triad Problems

By Gever, Senior Editor, MedPage Today

Published: February 23, 2011

Although FDA inspectors had reported a host of quality-control problems at Triad

Group long before it recalled millions of contaminated alcohol-based prep pads,

swabs, and jellies, the agency mysteriously took no corrective action, according

to an MSNBC.com report.

Citing FDA inspection reports provided by an anonymous source, the website

alleged that the agency knew about " shoddy sterilization practices " at Triad

Group's plant in 2009, yet did not issue a warning letter or alert customers or

physicians.

On Jan. 5 of this year, Triad announced a recall of all lots of isopropyl

alcohol prep pads, swabs, and swabsticks -- labeled as sterile as well as

nonsterile -- because of potential contamination by Bacillus cereus bacteria.

The company cited a single case of non-life-threatening skin infection as the

reason for the recall.

The firm's products were sold under the Triad name and as house brands for

Cardinal Health, CVS, Walgreens, and other retailers and distributors. The

recall was later expanded to include lubricating jellies sold by Triad as

sterile.

Firms such as Genentech that had packaged their injectable drugs with Triad prep

products were then forced to issue their own alerts.

But since the recall was announced, additional reports of infections associated

with the products have come to light -- including at least one death, according

to MSNBC.com.

The website described a two-year-old Texas boy who died of meningitis attributed

to B. cereus infection. The boy's parents are now suing Triad.

It also reported on a 55-year-old Tennessee man who contracted endomyocarditis,

allegedly after using a Triad pad packaged with Genentech's peginterferon

alfa-2a drug for hepatitis C. The man survived but required cardiac valve

replacement surgery in December, the website indicated. He too has filed suit

against Triad, with Genentech also named as a defendant.

The MSNBC.com report said that FDA inspectors had found " as early as July 2009 "

that sterilization procedures in Triad's plant in Hartland, Wis., were not being

followed.

The company had claimed to use gamma radiation to sterilize its products but the

inspectors were unable to validate the process, MSNBC.com said.

Inspectors reportedly also found that the company had shipped products that

failed to meet specifications, and had failed to investigate complaints about

faulty products from customers and to relay them to the FDA as required.

However, no warning letters or other follow-up action by the FDA ensued.

Contacted by MedPage Today, an FDA spokesman could not immediately confirm or

deny the MSNBC.com report or answer other questions about Triad, but promised a

response in due course.

Officials at Triad Group could not be reached for comment. The company's

Internet homepage indicated its website had been taken down for maintenance.

MSNBC.com quoted the FDA spokesman as saying the agency had not received any

adverse event reports about Triad products prior to the recall. During the first

month afterward, about 100 were filed, including 50 describing infections and

one involving a fatality.

The spokesman said the number of reports was typical for publicly announced

recalls. Only one report specifically identified B. cereus, according to

MSNBC.com.

He also told the website that another inspection had been conducted Jan. 7 that

disclosed " deviations from our current good manufacturing regulations, " but he

did not provide specifics. An investigation is ongoing, he said.

[Guest guest]

http://www.medpagetoday.com/Washington-Watch/FDAGeneral/25020?utm_content= & utm_m\

edium=email & utm_campaign=DailyHeadlines & utm_source=WC & em=shereemartinmsn

Questions Raised About FDA Handling of Triad Problems

By Gever, Senior Editor, MedPage Today

Published: February 23, 2011

Although FDA inspectors had reported a host of quality-control problems at Triad

Group long before it recalled millions of contaminated alcohol-based prep pads,

swabs, and jellies, the agency mysteriously took no corrective action, according

to an MSNBC.com report.

Citing FDA inspection reports provided by an anonymous source, the website

alleged that the agency knew about " shoddy sterilization practices " at Triad

Group's plant in 2009, yet did not issue a warning letter or alert customers or

physicians.

On Jan. 5 of this year, Triad announced a recall of all lots of isopropyl

alcohol prep pads, swabs, and swabsticks -- labeled as sterile as well as

nonsterile -- because of potential contamination by Bacillus cereus bacteria.

The company cited a single case of non-life-threatening skin infection as the

reason for the recall.

The firm's products were sold under the Triad name and as house brands for

Cardinal Health, CVS, Walgreens, and other retailers and distributors. The

recall was later expanded to include lubricating jellies sold by Triad as

sterile.

Firms such as Genentech that had packaged their injectable drugs with Triad prep

products were then forced to issue their own alerts.

But since the recall was announced, additional reports of infections associated

with the products have come to light -- including at least one death, according

to MSNBC.com.

The website described a two-year-old Texas boy who died of meningitis attributed

to B. cereus infection. The boy's parents are now suing Triad.

It also reported on a 55-year-old Tennessee man who contracted endomyocarditis,

allegedly after using a Triad pad packaged with Genentech's peginterferon

alfa-2a drug for hepatitis C. The man survived but required cardiac valve

replacement surgery in December, the website indicated. He too has filed suit

against Triad, with Genentech also named as a defendant.

The MSNBC.com report said that FDA inspectors had found " as early as July 2009 "

that sterilization procedures in Triad's plant in Hartland, Wis., were not being

followed.

The company had claimed to use gamma radiation to sterilize its products but the

inspectors were unable to validate the process, MSNBC.com said.

Inspectors reportedly also found that the company had shipped products that

failed to meet specifications, and had failed to investigate complaints about

faulty products from customers and to relay them to the FDA as required.

However, no warning letters or other follow-up action by the FDA ensued.

Contacted by MedPage Today, an FDA spokesman could not immediately confirm or

deny the MSNBC.com report or answer other questions about Triad, but promised a

response in due course.

Officials at Triad Group could not be reached for comment. The company's

Internet homepage indicated its website had been taken down for maintenance.

MSNBC.com quoted the FDA spokesman as saying the agency had not received any

adverse event reports about Triad products prior to the recall. During the first

month afterward, about 100 were filed, including 50 describing infections and

one involving a fatality.

The spokesman said the number of reports was typical for publicly announced

recalls. Only one report specifically identified B. cereus, according to

MSNBC.com.

He also told the website that another inspection had been conducted Jan. 7 that

disclosed " deviations from our current good manufacturing regulations, " but he

did not provide specifics. An investigation is ongoing, he said.