The U.S. Food and Drug Administration (FDA) has issued a warning letter to a Kansas-based dietary supplement maker, claiming that an investigation has revealed “significant deviations from current good manufacturing practice (CGMP) regulations for dietary supplements.”

According to FDA, “[t]hese violations cause dietary supplements manufactured at your facility to be adulterated.” Among the alleged violations are failing to (i) prepare and follow a written manufacturing record for each unique dietary supplement formulation the company makes; (ii) include complete information on the production and control of each batch in its batch production record, (iii) “collect and hold reserve samples of each lot of packaged and labeled dietary supplements” that it distributes; (iv) establish certain specifications, make and keep adequate documentation, “fulfill the requirements for reviewing and investigating product complaints,” “follow written procedures for handling returned dietary supplements”; and (iv) use hygienic practices to protect against product contamination. A response is required within 15 days of the June 23, 2014, letter date.