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NSF responds to Beehive Botanicals warning letter situation

05-Mar-2013

NSF International has responded to an article in NutraIngredients-USA on the FDA Warning Letter received by Beehive Botanicals after having GMP audits conducted by NSF.  A Beehive Botanical company official expressed dismay at getting the letter even after receiving a clean bill of GMP health from NSF.

Today, NSF responded with this statement:

General information regarding the NSF GMP Registration program:

In 2007, the FDA published new GMP regulations for dietary supplement manufacturers, giving manufacturers up to three years to comply with the regulations.  Since that time, the FDA GMP inspection program has evolved, with the FDA adopting more strict interpretations of the regulations over the last couple of years.    

With a public health and safety mission, NSF takes its public health role seriously and has been at the forefront in monitoring the FDA developments to help both manufacturers and auditors react to the evolving FDA GMP inspection program.  This includes working with the FDA to update the NSF audit checklist, to train NSF auditors to incorporate current FDA interpretations, and to incorporate feedback from FDA inspections into the NSF audit checklist and auditor training.  

With regard to NSF’s Beehive Botanicals GMP Registration

As opposed to product certification, NSF GMP Registration is a consultative audit process that is highly dependent on open, transparent communication.

NSF conducted a two day, annual/full audit in Fall 2011.  This resulted in findings consistent with the previous NSF audits as well as the then current FDA inspections of Beehive Botanicals.  In April 2012, NSF conducted a one-day monitoring audit, where NSF learned that the three previous FDA audits had not resulted in any Form 483 findings or, in other words, that the FDA believed Beehive Botanicals was in compliance with the then FDA GMP inspection program.  In July 2012, the FDA inspected Beehive and apparently issued Form 483 findings – NSF was not provided a copy of the Form 483 finding.  Thereafter, without the benefit of the Form 483 findings, NSF conducted its annual/full audit in October 2012, which identified many of the same issues that the FDA subsequently identified in the February 2013 warning letter.  In other words, many months before NSF knew of the FDA findings, NSF on its own, in accordance with its audit checklist and trained auditors, made most of the same findings as the FDA.  NSF required Beehive Botanicals to make corrective actions, which it did in October 2012.  We are unsure whether the corrective actions required by NSF were shared with the FDA.

NSF guidance on GMP compliance

Because the FDA GMP inspection program is evolving, a manufacturer cannot use prior inspections as the final barometer for continued GMP compliance. 

Here, had NSF received a copy of the Form 483 finding, NSF would have been better able to help Beehive address specific issues and findings in a timely manner, and perhaps avoiding the FDA warning letter issued 7 months later.  This is why manufacturers are encouraged to immediately advise NSF of any regulatory inspections, resulting Form 483 findings and warning letters.

The lesson here is that it is in everyone’s interest to share FDA inspection reports with your GMP auditor and allow NSF to assist in responding to corrective actions.

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