After the FDAs 1998 inspection, the agency sent a warning letter to the company, outlining the findings from its review and instructing the company to look into its software-development process and correct the deficiencies noted in its report. The agency told Multidata that if the company didnt take care of the problems, the FDA would be forced to take further action, which could include fines and an injunction against the company.
The FDA also told Multidata it wanted the company to notify the agency within 15 days of the steps the vendor was going to take to address the problems.
According to the subsequent FDA reports, Multidata never responded to the 1998 letter.
"We usually get action from our warning letters," Rodriguez says. Multidatas Roestel admits that the company did not respond to the FDAs letter.
In 2001, after the deaths in Panama, FDA inspectors found many of the same problems they found earlier. Multidata, it said, had no mechanisms for addressing incomplete or ambiguous software requirements, customer complaints were not being properly recorded, and there was no comprehensive testing plan to demonstrate that its software was "fit for use."
Conley says the company has been working hard to rectify the complaints identified in the FDAs 2001 inspection. He says Multidata, in fact, was looking for ways to better track software fixes and problems, including the installation of a computerized system to record and store customer complaints, when the FDA issued its injunction.
Conley admits Multidata didnt address issues quickly enough for the FDA.
"Were a small company that didnt always react in a timely fashion," he says. "We did what we were supposed to do, [but] we didnt file the proper reports for it."
To have the injunction lifted, the FDA says Multidata must improve its design and manufacturing methods; upgrade its record-keeping mechanisms; and retain a medical-device design expert to inspect the companys manufacturing activities, check over its software code, and report back to the FDA. The outside expert must have no financial ties to the company other than the consulting agreement for this series of tasks.
Conley said in February 2004 that Multidata will have its development practices reviewed by Bio-Reg Associates Inc., which describes itself as a "regulatory consulting firm conveniently located close to the FDA in Washington, D.C.
"They are staking their reputation on the line by representing us to the FDA," Conley says. "They would not take us if we were a shlock outfit."
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