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After news broke this week about a North Carolina factory tied to bacteria-tainted syringes that killed five patients, criminal investigators revealed a telling fact: The company’s “chief microbiologist” was a teenage high school dropout. This week, two former employees of the AM2PAT manufacturing center in Angier, N.C., pleaded guilty in federal court to charges related to falsifying documents and shipping bacteria-tainted syringes full of blood thinners meant for patients receiving intravenous fluids.
Authorities are still seeking the company’s owner, who will face a 10-count indictment. In addition to the deaths, more than 200 people were sickened by contaminated syringes. The case raises a glaring question: As this biological tragedy was taking shape, where was the agency charged with standing between Americans and deadly medicine?
The Food and Drug Administration, it turns out, was aware of problems at the 40-employee lab as early as 2005. According to a letter it released Wednesday to ProPublica and the Raleigh News & Observer, the FDA warned the company in August of 2005 about “serious violations” and ordered the firm to change its practices. During a June 2005 inspection of the company, the FDA found nine “significant [quality] violations,” the letter says.
The company failed to conduct routine tests on its syringe-filling machine. The daily log of the “clean room” was only filled out once a month, the letter states. The company’s complaint-response system was in disarray. And employees were not properly trained: One was chewing gum while filling syringes; another was “improperly gowning” during sterility tests.
FYI.
