Beehive’s counsel, Marc Ullman, an attorney with Ullman, Shapiro & Ullman, said from the company’s point of view, the sequence of events is important in understanding why the receipt of the warning letter was greeted with such dismay and disbelief.
“NSF is in the facility on April 24, 2012. There are no observations. FDA is in on July 25, eight weeks later, and that inspection results in the 483,” Ullman told NutraIngredients-USA.
There followed an exchange of e-mails, in which Ullman says Beehive told NSF that the company had received a 483. NSF’s response was to recommend that Beehive pay an additional fee to hire NSF’s consulting arm to help the company fix the problems FDA observed but that the NSF auditor missed. Beehive, believing that the 483 observations could not have been very serious after receiving a clean sheet from NSF such a short time before, chose not to take that path and responded to the 483 themselves, without NSF’s, Ullman’s or other outside help. Beehive Botanicals CEO Linda Graham now admits this was a mistake.
“So in August, Beehive responds on their own to the 483, then we have a gap where FDA is analyzing that response,” Ullman said.
“In the near term, in October, NSF is back in the facility. So they do their two day audit, which includes looking at documentation that the company has modified in response to the 483. And the NSF auditor concludes (quoting from the report) ‘unique operations associated with natural products components processing procedures and documentation reflect satisfactory compliance with GMP standards.’
“While he caught in his observations a couple of things FDA objected to (in the warning letter), his Observation 82 stated ‘component specifications were acceptable,’ which was item one on FDA’s warning letter.”
Communication breakdown
Ed Wyszumiala, general manager of dietary supplement certification for NSF, said his company was not fully aware of the scope of the 483 that Beehive received, and that breakdown in communication contributed to the subsequent warning letter situation.
“The issue here is that the Form 483 by FDA to Beehive was not immediately disclosed to NSF, and to date, NSF has yet to receive a copy of the Beehive Form 483. In this case, Beehive emailed NSF representative two questions on August 9, 2012, which Beehive said arose from a recent FDA inspection. NSF responded with general industry information but said that if Beehive needed specific assistance addressing these two questions, they would need to work with the separate NSF consulting group,” Wyszumiala said.
“NSF believes it is important to maintain separation between registration audits and consulting on fixing the problems, in order to avoid even a perceived conflict of interest. In this case, contacting an auditor from the NSF consulting group (formerly NSF-DBA) was recommended. The NSF consulting group will typically draft a scope of work and quote based on the manufacturer’s submitted Form 483. Beehive did not initiate this consulting project,” he said.
While granting that there is a difference in consulting and auditing, Ullman said that still doesn’t explain why FDA cited specific things as serious deficiencies that NSF said were OK. He said from Beehive’s point of view, NSF had ample opportunity within the auditing process to alert the company to serious violations of GMP rules. And he characterized as a case of “hubris” the idea that NSF had suggested hiring an NSF consultant to help deal with NSF auditor issues.
“NSF is in the facility before FDA comments, and after the company responded to that 483 but before the agency’s comment on that response, and NSF finds them in compliance (in all cases). That timeline is very important,” Ullman said.