With failure to clean up its manufacturing practices after years of federal warnings, Kabco Pharmaceuticals is now facing an injunction to stop producing and selling its dietary supplements.
Manufacturing photo from Kabco Pharmaceuticals.
The U.S. Justice Department filed the injunction accusing the company of implementing inferior product safety and manufacturing practices, and producing dietary supplements that are potentially dangerous to people’s health.
The products produced by the company include: Brewers Yeast Tablets, Dandelion Root Capsules, Night-Time Herb Capsules, Inositol Calcium & Magnesium Capsules, Vitamin C-500 with Rose Hip Time-Released Tablets, and Joint All Capsules.
An investigation by the U.S. Federal Food and Drug Administration found that, “The company did not review and investigate product complaints, and Kabco also failed to hold dietary supplements under conditions designed to prevent product mix-ups.”
In November 2010, the FDA sent a warming letter to Kabco citing a number of violations. The allegations included that the company “did not perform identity testing on any of the dietary ingredients” received from distributors, such as valerian root (a sedative for sleep problems and anxiety) and ginkgo biloba (an aide for memory and concentration improvement).
The FDA also accused the company of failing to indicate what steps it would take “regarding already distributed dietary supplements” made from untested ingredients.
The FDA added that the company “failed to use effective measures to protect against the inclusion of metals and other foreign materials” in their supplements, and that investigators observed supplements going through conveyor belt packaging lines without passing through a metal detector.
The agency also accused to company of failing to properly label and preserve its ingredients so as to avoid the “mix-up, contamination, or deterioration of components.”
The FDA further told the company that it failed to fit each freezer, refrigerator, and other cold storage compartment with appropriate indicating thermometers to ensure the proper preservation of the ingredients used in its supplements.
There have also been sanitary issues. The agency also told Kabco that it “failed to make and keep complete documentation of when cleaning of mixing equipment occurred.”
The FDA warmed the company that “failure to promptly correct the violations” could result in the seizure of violating products, and/or an injunction against the company, which has now been filed by the U.S. Justice Department.
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