[September FDA] warning letter those changes and updates are not reflected,” she says.
Her agency told the FDA last spring that Zoka was cleared to roast again but did not give it details that would take the place of Zoka communicating its efforts directly to the FDA, she said.
FDA spokesman Alan Bennett says he can’t speculate about whether Zoka would have gotten a warning letter if it had responded earlier.
Warning letters are meant to tell companies they’re doing something wrong, not to warn the public, Bennett says. And a company can ask the FDA to post its response to a warning letter on the agency’s website.
Babcock says he has now replied to the FDA’s letter and expects another inspection at some point. He also plans to ask that Zoka’s response be posted on the FDA’s website.
Meanwhile, the state inspected Zoka’s roastery on Sept. 14 and gave it a passing score of 93 out of 100. Its last regular state inspection was on Aug. 24, 2010, when it received a 96.
Business has been hurt “maybe a little,” Babcock says. “We had people saying terrible things that were not true.”
The rhetoric cooled when Zoka posted a response on its website, explaining what had happened.
“We offered anybody to come look at the roastery any time they want,” he says. “My intention is to make it and keep it the cleanest roastery on West Coast, so it never happens again.”
— Melissa Allison, email@example.com
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