HAYWOOD, Wis.—After a March 31 product seizure by U.S. Marshals, acting on behest of FDA, Beehive Botanicals is taking action to ensure the company is back in full compliance and operating at capacity as quickly as possible. Linda Graham, the president and CEO of Beehive Botanicals, told INSIDER the company has filed a notice of claim on goods and hopes to have substantive conversations with the agency early next week.
According to Graham, the crux of FDA’s current complaint hinges on a single Web link, which was in fact a beta testing site developed by a contract employee that should not have been visible to the public. It was still connected to the Beehive Botanicals site after the company took extensive actions to address FDA’s concerns about labeling and claims in a 2007 warning letter. “We are prepared to show that we took these actions in good faith and thought we were in compliance almost three years ago,” Graham said. “We’re not a company that’s trying to do anything illegal. We’re shocked that they would go to this extent to seize products, and our company, our reputation and our 47 employees are at stake.”
However, the company is prepared for meetings with FDA and is aiming to resume its normal operations as soon as it can get material back in the pipeline. Graham noted, “We want to make it clear to our customers, as FDA did, that this is not a quality issue. As a contract manufacturer, we’re still here and producing high-quality goods in a GMP-compliant facility that is audited by NSF International.”