FDA cited problems at plant linked to contaminated syringes

RALEIGH — The operators of a company that shipped bacteria-tainted syringes linked to at least five deaths had been warned by the U.S. Food and Drug Administration about serious problems at a previous plant.

The Aug. 11, 2005, warning letter, provided by the FDA on Wednesday, 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 on Ransdell Road, 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.

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