By SARAH AVERY
Raleigh News and Observer
February 26, 2009
The Aug. 11, 2005 warning letter, provided by the FDA this week, foreshadowed the legal problems now facing AM2PAT Inc. and its officials, who have been charged with falsifying sterility records on pre-filled heparin and saline syringes that sickened more than 100.
The violations, which arose while AM2PAT operated its plant south of Raleigh, N.C., were "symptomatic of serious underlying problems" in the company's quality control system, the FDA's warning letter stated.
Investigators noted lax documentation of sterility tests, workers untrained for their jobs, and slack efforts to maintain and monitor a sterile environment.
"Evidence of improperly trained personnel included an employee chewing gum while filling syringes and an employee improperly gowning during sterility test," the warning letter stated.
In all, the 2005 letter cited nine serious breaches, suggesting a company in chronic violation of FDA rules designed to assure that drug devices are safe.
"It's startling," said Richard D. Kiernan, who retired as vice president and director of worldwide research and development compliance with GlaxoWellcome, now GlaxoSmithKline.
Kiernan, who worked under FDA regulations, said the findings in the warning letter were serious enough to shut the facility two years ago.
He characterized several of the nine violations as critical. Among the worst findings, Kiernan said, was the company's failure to make sure equipment and procedures were operating according to a carefully calibrated system -- a key requirement when filling syringes with medicines that need to be precisely measured and absolutely sterile.
Earlier this week, two of the company's former plant operators pleaded guilty in U.S. District Court to falsifying documents to make it appear that the syringes underwent sterility testing. Aniruddha Patel, plant manager, and Ravindra Sharma, director of quality control, were each sentenced to 4 1/2 years in federal prison.
The company's president, Dushyant Patel, faces 10 charges and is the subject of an international manhunt. He is believed to have returned to his native India.
The FDA letter said the findings in the warning letter were "not intended to be an all-inclusive list of the deficiencies" at the facility. It demanded that AM2PAT officials offer "prompt action to correct these deviations."
An FDA spokeswoman, Siobhan DeLancey, said inspectors conducted a follow-up probe in January 2006. Results of that inspection were not available, but have been requested under the Freedom of Information Act.
In June 2007, the company moved from Raleigh to Angier, N.C., setting up in a facility that previously housed the Moto Guzzi Motorcycle manufacturing plant. Not long after, complaints began making their way to the FDA about sediment and particles in some of the saline syringes shipped from the company's Angier facility. The normally clear medicine was muddy brown or orange.
By December 2007, syringes infected with the Serratia bacteria were traced to the Angier plant. At least 100 patients receiving chemotherapy, kidney dialysis and other intravenous treatments were sickened by the outbreak. Many people suffered severe injury, and at least five deaths are associated with the infection.
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Scripps Howard News Service, http://www.scrippsnews.com
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