FDA WARNING_LETTER - Create-A-Pack Foods, Inc. - April 20, 2017

From January 23 to April 20, 2017, the FDA inspected Create-A-Pack Foods, Inc. in Ixonia, Wisconsin, and found violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering their products adulterated under 21 U.S.C. § 342(g)(1). Additionally, product labels for the (b)(4) Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its components ((b)(4) Herbal Cleanse Intensive Cleansing Blend and (b)(4) Herbal Cleanse Precleansing Blend) were found to violate food labeling requirements (21 U.S.C. § 343 and 21 CFR Part 101), making them misbranded.

Significant CGMP violations included: 1. Quality control personnel failed to reject or approve treatment for components not meeting specifications. Specifically, burdock root extract exceeding microbiological specifications was used, and nettle leaf extract lot (b)(4) was used despite failing identity testing. The firm's response regarding "active ingredient" testing for nettle leaf extract was deemed inadequate as it did not confirm identity or address preventing release of out-of-specification components. 2. Quality control personnel approved and released batches of dietary supplements where components (nettle leaf extract lot (b)(4)) did not meet identity specifications