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Thursday, July 22, 2010

GMPs & Warning Letters for Dietary Supplement Companies


I trust that summer is flying by for those of you in the Northern Hemisphere and I hope that winter is not too harsh for those of you in the Southern Hemisphere.

Since dietary supplement companies are now required to comply with FDA’s Good Manufacturing Practices (GMP) regulations, the agency has begun increased inspections and enforcement actions as promised.  In March the agency posted the first warning letter based on the dietary supplement GMPs. The following deficiencies in adherence to GMPs were noted:

  1. Failure to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use. In this particular case the company was using an aloe vera gel but the testing methods used were not sufficient to know if the aloe were pure or if it was “a mixture of aloe, thickeners and/or other ingredients.”
  2. Failure “to make and keep documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement”.  So the company had in process tests set up but those processes and tests were not relevant to the product.
  3. Failure to “follow your written procedure, ‘Approval/Rejection of Raw Materials and Packaging Components’ for collecting representative samples of each unique shipment of components.”  In other words, the company had standard operating procedures but did not follow them.

The letter goes on to cite several deficiencies with the quality control program, batch records and manufacturing records.  You can read the entire letter at .

Our goal at Bioscience Translation & Application is to facilitate your success.  We work in association with former FDA staffers who provide GMP and pre-inspection assistance.  Let us know if you need help complying with these regulations. Learn more at

You may also be interested in attending a GMP class being offered at the Supply Side West meeting to be held in October in Las Vegas.  While I have not seen the curriculum, the course is being offered by reputable companies.  For course details visit

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