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Supplement maker tells customers it's ‘business as usual’ despite GMP warning letter

1 commentBy Shane Starling , 22-Mar-2011
Last updated on 28-Jul-2014 at 21:06 GMT

Vital Nutrients:
Vital Nutrients: "We are taking every measure to satisfy any and all concerns of the FDA"

Connecticut-based dietary supplements manufacturer Vital Nutrients has written an open letter to its customers to assure them that the recent FDA warning letter it received over GMP issues were predominantly of an administrative nature” and not a reflection on quality.

As a manufacturer of dietary supplements, we have held one point of view concerning product quality; quite simply, that our brand should reflect at all times a standard of excellence that is unquestionable,” the company wrote, adding more specifically of the FDA’s 2010 ‘483’ inspection of its facilities:

 

“The FDA was extremely thorough and we believe that both parties benefited from this exercise which will have a far-reaching influence on our entire industry.”

 

“While the violations cited were predominantly of an administrative nature, we further believe that none of the recommended corrective actions point to ingredient deficiencies that would influence the quality of our products. Moreover, we are taking every measure to satisfy any and all concerns of the FDA. We respect their diligence in executing the directives of their office.”

 

The Food and Drug Administration warning letter , issued February 16, 2011, found Vital Nutrients (trading as RHG & Company Inc) deficient in areas such as batch testing; component specifications for purity, strength and composition; specification of bulk powder density; failing to conduct material reviews and failing to maintain master manufacturing records for each of its products.

 

Products included vitamin D supplements, ‘PreNatal’ multivitamins and garlic extracts.

 

Vital Nutrients responded to the FDA points, but the FDA’s district director in its New England office, Mutahar S Shamsi, wrote in the warning letter:

 

 “Your letter stated that you will conduct full profile finished product testing until you ‘have adequate data and documentation on file to exempt any testing’,” the FDA wrote.

 

“However, you did not provide documentation that you conducted finished product testing of each finished batch of dietary supplement to verify that each batch met the finished product specification for strength and did not provide documentation that your firm is currently conducting such finished product testing for strength.”

 

Open to discussion

 

In its open letter to its customers Vital Nutrients said the company was ready and willing to discuss the content of its exchanges with the FDA with customers and suppliers.

 

The company posted a statement on its website outlining why it believes its processes actually exceed FDA Good Manufacturing Practice standards. It noted this was the case because it never relied on Certificates of Analysis in isolation; did not engage in skip lot testing; tested for aflatoxins on herbal materials and more.

1 comment (Comments are now closed)

this company is not leveling with the public

I strongly disagree with the company's responses that the items in the Warning Letter are mostly of an "administrative nature". I've been in this business for more than 50 years and have served as a subject matter expert to the FDA and 500 companies worldwide and this company still doesn't appear to understand the regulations. They simply don't get it. What a shame!

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Posted by Bill Hall, Ph.D.
25 March 2011 | 12h10

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