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Posted February 17, 2012

FDA Warns Supplement Company of Manufacturing Violations

The U.S. FDA recently posted a Warning Letter to Pure Encapsulations, Inc. (dated December 23, 2011) regarding violations of Current Good Manufacturing Practices for dietary supplements based on an inspection of its facility in Sudbury, MA in August 2011 and affecting the company's PhytoBalance products.

The inspection revealed that the company failed to reject an ingredient that did not meet its identity specifications and then used this ingredient to manufacture the finished product, PhytoBalance. The FDA also noted that the analytical tests used by Pure Encapsulations to determine ingredient identity were inappropriate and not scientifically valid. The company apparently used organoleptic testing (i.e., taste, smell, feel, or appearance) and a review of certificates of analyses for comparative identity testing, but, according to the FDA, "There is no ability to distinguish these ingredients from other powder ingredients through gross organoleptic analysis."

The FDA also warned that the PhytoBalance dietary supplement is misbranded because the label fails to declare the common or usual name of each of its ingredients. For example, the label does not declare 1) the sub-ingredients of the vegetable capsules used to manufacture the product and 2) the common or usual name of each botanical ingredient.

Pure Encapsulations responded that it is taking actions to correct these deficiencies and the FDA responded that such actions should be adequate but will be verified during their next inspection or upon receipt of documentation provided by Pure Encapsulations.'s has published tests and reviews of several Pure Encapsulations products.

The Warning Letter is available on the FDA website using the link below: