ISO Quality Control Director!

ISO Quality Control Director!

August 2nd, 2012 // 5:09 pm @


We normally confine ourselves to pharmaceutical matters on this site, but every so often, an interesting item of some other sort passes by and so we take notice. In this instance, the FDA issued a July 24 warning letter to United Nutrition Labs, which makes several dietary supplements, but had some difficulty, among many other things, locating a qualified quality control director. A great deal of difficulty, in fact.

The letter follows up a December 2011, inspection and subsequent 483 report that found United Nutrition “failed to establish product specifications for the identity, purity, strength, and composition of each batch of finished dietary supplements and also failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, before being used as a dietary ingredient.”

There were other manufacturing problems, but the item that stood out concerned an inability to find a quality control director, which may explain the various issues cited in the letter. Specifically, the FDA noted that the quality control director “is not qualified to perform her assigned functions in that she does not have the experience, knowledge, and level of training necessary to perform the functions of this position” (here is the letter).

In fact, the company previously employed three quality control directors since an October 2010, inspection, none of whom were qualified to hold this position. As of last January, United Nutrition committed to finding a qualified prospect and ensure they undergo the proper training. Whether the company has been successful is unclear. We called for comment and will update you accordingly. It may be a tough economy, but there is at least one job opening.

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