- The Washington Times - Friday, March 20, 2009

The U.S. Food and Drug Administration released a series of documents Friday about a North Carolina syringe factory, including inspection reports of AM2PAT Inc. and a complaint filed by an employee of the company. Here’s a timeline of the company’s history:


_ June: U.S. Food and Drug Administration inspects Chicago-based AM2PAT Inc.’s facility in Raleigh, N.C., after receiving a complaint about a cracked syringe and another syringe that contained floating material. The FDA found no evidence of contamination.

_ Aug. 11: FDA sends a letter to AM2PAT citing “several significant violations” in its quality control system, as found during the June inspection. They include unqualified workers, poor documentation and insufficient efforts to maintain a sterile environment.

_ Nov. 15: FDA receives complaint that someone found particles inside a heparin solution manufactured by AM2PAT.


_ Jan. 17: FDA begins re-inspection at AM2PAT, later concluding the facility is satisfactory.


_ March 20: FDA receives a complaint that a patient’s husband saw “both brown and black particulate matter found throughout unopened flush syringe.” The patient was hospitalized with a blood infection. The company later said the sample was not available for evaluation but that it tested samples from the same lot. FDA records do not show those results.

_ May: AM2PAT moves its production from a building in Raleigh to a facility in Angier, N.C.

_ May 1: FDA receives a complaint that “white particulate matter of various sizes” was found in multiple syringes produced by Sierra Pre-Filled, another name for AM2PAT.

_ June 6: FDA receives a complaint that “white precipitate or powder” was found in syringe produced by Sierra Pre-Filled.

_ June 20: AM2PAT employee complains in an e-mail to FDA the company is not adhering to temperature guidelines in its cleanroom. Person also says management ignored complaints and wouldn’t allow employees to talk to FDA during a previous inspection.

_ June 26: FDA tries to inspect AM2PAT facility, but visits the company’s old location. Inspector calls employee and learns that company had moved to Angier two months prior.

_ Aug 1: FDA inspects AM2PAT’s new facility and discusses a labeling problem with the firm, but notes no other problems.

_ Aug. 24: FDA begins receiving a series of almost a dozen complaints of “muddy brown,” yellow, orange and “dingy” syringes, some with debris.

_ Dec. 11: The Centers for Disease Control and Prevention advises the FDA of two clusters of infections linked to flushes produced at AM2PAT. Prosecutors say the tainted lot sickened hundreds and killed five.

_ Dec. 13: FDA initiates inspection of AM2PAT. Inspectors find “numerous violations that made it impossible for the company to maintain sterility in the product.”

_ Dec. 20: AM2PAT issues nationwide recall of product found to be contaminated with bacteria. The company begins shutting down.


_ Jan. 18: AM2PAT expands nationwide recall of syringes.

_ April: Prosecutors file criminal complaints against two AM2PAT workers.


_ Feb. 19: Prosecutors indict AM2PAT chief executive Patel Dushyant on a range of charges and begin an international search for him. Authorities believe he has fled to his native India.

_ Feb. 23: Former AM2PAT plant manager Aniruddha Patel, 43, of Carpentersville, Ill., and quality control director Ravindra Kumar Sharma, 54, of Richmond, Va., are sentenced to 4 1/2 years in prison each for fraud and allowing tainted drugs into the marketplace.


Sources: U.S. Food and Drug Administration; FDA records; court documents.



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