A dietary supplement manufacturer is on notice from the FDA because the firm’s products were prepared, packed, or held under conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to heath.
Staff from the Food and Drug Administration inspected the Ixonia, WI, location of Create-A-Pack Foods Inc. from Jan. 23 to April 20, and discovered “serious violations” of the Current Good Manfacturing Practice (CGMP) regulation for foods, according to a Nov. 2, warning letter, made public by the FDA in recent days.
Additionally, review of the firm’s product labels resulted in misbranding violations. “We conclude that your Herbal Cleanse 5 Day Cleansing Program Dietary Supplement boxed kit and its bottled components Herbal Cleanse Intensive Cleansing Blend and Herbal Cleanse Precleansing Blend products violate section 403 of the Act, 21 U.S.C. § 343, and regulations implementing the food labeling requirements of the Act,” according to the letter sent to Glenn M. Cochrane, president of Create-A-Pack Foods Inc.
Specifically, FDA’s Division 1, West Director Michael Dutcher, noted the following observations logged during the inspection:
- The firm used the ingredient “burdock root extract” that exceeded their microbiological specifications in the manufacture of their Herbal Cleanse Precleansing Blend and Herbal Cleanse Intensive Cleansing Blend Dietary Supplement products.
- The firm used the ingredient nettle leaf extract lot in the manufacture of their Herbal Cleanse Precleansing Blend Dietary Supplement and Herbal Cleanse Intensive Cleansing Blend Dietary Supplement products, but the ingredient did not meet its established component specification for identity.
- The firm released into distribution Herbal Cleanse Precleansing Blend and Herbal Cleanse Intensive Cleansing Blend products, for which the nettle leaf extract lot was found to not meet its identity specification because testing of the component on two separate occasions found the component to consist of nettle leaf.
- The firm failed to confirm the identity of other components (not including dietary ingredients) and determine whether other applicable component specifications established are met.
- The firm failed to maintain documentation of how they qualified the supplier, and periodically reconfirm the supplier.
- The bottle labels fail to list the serving size in common or usual household measure, i.e., one bottle.
- The box label fails to list the number of servings per container (box) of each of the dietary supplement components contained
- The labels fail to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement.
- The products contain extracts of burdock root, milk thistle seed, nettle leaf, and Uva ursi leaf, but the product labels fail to state that the ingredients are extracts.
- The firm failed to list magnesium lactate as an ingredient, even though it is used in the product.
- “Maganese” is incorrectly spelled on the Supplement Facts labels for the three products.
The FDA noted a response letter from firm on May 10, but were “unable to evaluate the adequacy of your corrective actions because you did not provide documentation showing that you have qualified your supplier or the supplier’s COA, and the third party laboratory COA does not include identity testing.” The FDA said they would evaluate the adequacy of the firm’s corrective actions at their next inspection.
Food companies are given 15 working days to respond to FDA warning letters. “You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction,” according to the warning letter.
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