The US Food and Drug Administration (FDA) has again shown that it will go beyond just sending warning letters for GMP violations after filing an injunction against a NY supplement manufacturer.
FDA is seeking to halt the production and distribution of dietary supplements by Amityville, NY-based Kabco Pharmaceuticals Inc., and its owner Abu Kabir until they comply with the Federal Food, Drug and Cosmetic Act and current good manufacturing practice (cGMP) requirements for dietary supplements.
“FDA works with firms to ensure that their processes comply with the public health requirements in our laws and regulations,” said Dara Corrigan, associate commissioner for regulatory affairs. “But when a firm refuses to comply, we will take aggressive enforcement action.”
FDA has placed GMP compliance at the forefront of its efforts. Speaking at the American Herbal Products Association's (AHPA) inaugural Botanical Congress in New York in May, FDA’s Dr Daniel Fabricant told attendees that the agency viewed GMP compliance as the biggest issue for the industry. In 2011 FDA conducted 175 GMP inspections, filed its first injunction, and seized products for the first time.
Only seven GMP inspections occurred in 2008, which increased to 34 in 2009, and 84 in 2010, according to FDA data. As of May 2012, FDA already had 38 inspections "under its belt".
FDA randomly samples dietary supplement firms based on the firms registered with FDA in accordance with the ‘Bioterrorism Act”.
Kabco Pharmaceuticals Inc. received a warning letter from FDA in 2010 (available here ) for “a number of violations of 21 CFR Part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements”.
According to FDA, 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.
The dietary supplements produced by Kabco Pharmaceuticals include Brewers Yeast Tablets, Dandelion Root Capsules, Night-Time Herb Capsules, Inositol Calcium & Magnesium Capsules, Vitamin C-500 with Rose Hips Time Released Tablets, and Joint All Capsules.
The complaint was filed in the U.S. District Court for the Eastern District of New York. If entered, the injunction would require Kabco to stop manufacturing and distributing dietary supplements until, among other corrective actions, the company demonstrates to the FDA that it is meeting the quality, safety, and labeling standards required by law.
Requests for comment from NutraIngredients-USA went unanswered by Kabco Pharmaceuticals Inc.
According to the company’s website: “Our quality products begin with purchase of the finest ingredients and packaging materials from carefully selected suppliers.
“Incoming raw materials undergo stringent quality control inspections - for potency, and purity - to assure conformance to the product specifications. Careful storage and handling of raw materials maintain optimal viability of all components.”