Beehive Botanicals taken aback by FDA warning letter

CEO says issues in the letter were not raised in audits.

In order to insure quality assurance at the level they expect of themselves, Beehive Botanicals Inc. has asked the EAS Consulting Group and Beehive’s council Ullman Shapiro & Ullman to assist in resolving issues raised by FDA in a Warning Letter dated Feb. 8, 2013. The Warning Letter was in response to FDA’s finding Beehive Botanicals’ responses to FDA 483 cGMP observations inadequate.

“We were taken aback by the Warning Letter because we have made a significant investment in third party cGMP certification by NSF since 2007, including two audits of our facility each year. In fact, we just received 2013 NSF GMP certification based upon an audit they did after FDA issued the 483 observations, and none of those issues were raised, so you can imagine our dismay,” said Beehive Botanicals’ president and CEO, Linda Graham.

“NSF apparently missed things that FDA didn’t. Believing NSF would have identified those issues if they were serious, we responded to FDA ourselves, rather than consulting counsel. In retrospect that was a mistake,” Graham continued. “We have now brought in the best experts we could find. Going forward, Beehive is firmly committed to working with EAS to assure our on-going compliance in keeping with our pledge to give our customers the best products possible.”

Beehive is working with EAS and the Ullman firm to do a thorough GMP review as relates to component specification and test methods, and to review the company’s MMR record template to ensure all required elements are covered.

GMP audits, whether by FDA or a third party certification organization, generally result in identifying things that could be done better, which is how most manufacturers continually improve and fine tune their quality programs. 

“As FDA becomes ever more vigilant about cGMP compliance, it’s crucial for companies to constantly work to improve and fine tune quality assurance and cGMP procedures,” said prominent industry regulatory attorney Marc Ullman, partner in Ullman Shapiro & Ullman. “If your third party audits are not identifying ways to improve and fine tune, that is a red flag. We are confident we will resolve all of the immediate issues as well continuously work to improve going forward.”

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