Naturavit GMP Case Highlights Education Need

WASHINGTONFDA has sent a warning letter to Miami, Fla.-based Nutravit Inc. highlighting not only the serious GMP (good manufacturing practices) violations uncovered by the agency's early 2012  inspection of the company's facilities, but also the company's apparent lack of awareness of what GMPs and some of the violations mean.

Among the list of violations, Nutravit failed to create or maintain master manufacturing records (MMRs) and batch records for its Liquid Collagen product . Upon questioning from FDA inspectors, the company admitted it didn't have any such records for any of its dietary supplements. Other documentation violations include lack of written records and procedures for holding, distribution, labeling, product complaints and returns. In addition, the company failed to conduct tests on incoming materials, relying instead on certificates of analysis (COAs) from vendors that were not qualified according to the regulation. The company admitted to inspectors they routinely rely only on COAs and do not qualify vendors. Finally, Nutravit did not keep reserve samples and store dietary supplements appropriately to avoid contamination and other problems, and failed to designate and train personnel responsible for quality control.

Above and beyond all the GMP violations, FDA reviewed labels acquired by the inspectors and found rampant disease and drug claims that render the products as unapproved new drugs. Labels for Nutravit's Noni Imperial Hawaiian claimed the product could treat several conditions including diabetes, gastric ulcers, arthritis, heart disease, high blood pressure, kidney disorder and pain. Other offending products included Garlic & parsley, Cholestol, Nopal and Diatrin.

FDA advised the company to respond within 15 days with specific details on how it is correcting the problems, supported by documentation. Noting the company apparent admission to not knowing the requirements, the agency suggested the company hire a consultant or other help in bringing them up to speed on GMPs for dietary supplements and for training personnel.

INSIDER's Take:

This may be the first warning letter showcasing a company that admits to not knowing the dietary supplement GMP regulation and its requirements. Whether this is a case of feigning ignorancemany companies figure they won't spend on compliance until they absolutely have toor an unlikely case of having no clue there are GMP requirement to follow for dietary supplement manufacturing, this is a company that is in a bad position and now must either undertake an expensive scramble to bring their operations into compliance or fold their operations. Nutravit could well be one of the primary types of supplement operations the GMP regulation is expected to cull.  At the very least, this is a company and case that frustrates the responsible dietary supplement companies that have invested in compliance.