That leaves the pharmaceutical companies to police themselves. Baxter did conduct its own inspection last September and gave itself a passing grade, just months before Americans began dying from contaminated heparin.
"It is clearly our job to make sure that our therapies are safe, for which we have our own inspections and our own audits," said Baxter's chief scientist, Norbert Riedel. "But it is also the responsibility of the FDA to provide the necessary oversight and checks and balances than that is indeed occurring."
Riedel says that Baxter has formed a task force to examine the oversight process.
"We have put a team of scientists in place, and I'm chartering them with the task of asking where else could any one of our products be tampered with in this fashion," he said.
But Riedel points out that additional inspectors may not have saved any lives from the spiked heparin.
"I think the contaminant was made to be so similar to heparin that no test that we had in place and no facility inspection could have found it," he said.
A number of families, including the Hubley's, are now suing Baxter for wrongful death.
While there may be disagreement about how best to provide oversight, there is no argument in Soon-Shiong's mind.
"Some contaminant was absolutely added," he said. "But there were some ways to protect and prevent not just the additive, but to control the supply chain and catch it very early on."
Leroy Hubley might agree with the need for control when many precious lives hang in the balance.
"Now I am left only to deal with the pain of my wife and son, [knowing] that the unsafe drug was permitted to be sold in this country," he said. "The FDA and Baxter have not done their job. Somebody sure as hell didn't."
Article updated July 31, 2008.
ABCNews.com producer Katie Escherich contributed to this report.