After a history of GMP compliance failures, dietary supplement manaufacturer Kabco Pharmaceuticals has been shut down by FDA until such time that it can meet the stipulations of a consent decree.
Kabco, with headquarters in Amityville, New York and offices in the Czech Republic and in Bangladesh, received a warning letter in 2010 and was subject to a previous injunction issued in July, 2012. Now Kabco, and its CEO, Abu Kabit, have entered into a consent decree of permanent injuction that enjoins the company from violating the Federal Food, Drug and Cosmetic Act (FDCA) in connection with their manufacturing, packing and distributing of dietary supplements.
In a complaint filed with the court, the United States alleged that FDA inspections found that Kabco, a contract manufacturer, distributed dietary supplements, including 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, that did not meet product specifications. (Those were the products detailed in the complaint; Kabco, on its website, says it can offer 2,500 different products.)
During inspections of Kabco’s plant, FDA found numerous GMP violations. Among other violations, Kabco did not review and investigate product complaints, failed to hold dietary supplements under conditions designed to prevent product mix-ups and included unlabeled raw ingredients in their dietary supplements, including whey, an undeclared allergen.
Enforcement ramping up
Industry observers agreed that it is a sign that the Food and Drug Administration is losing patience with industry noncompliance and that enforcement actions are ramping up.
“We’ve seen a handful of supplement manufacturers shut down for persistent GMP violations in the last year,” attorney Marc Ullman of the firm Ullman, Shapiro & Ullman told NutraIngredients-USA.
“If you go back and look at the complaint, Kabco had a serious of warning letters. The message is clear: If you don’t want to or cannot comply, FDA will shut you down,” he said.
“I think for a lot companies that have spent a lot of money and time coming into compliance, this is good news for the industry.”
“I think that it signifies to the industry that FDA means business. And that’s a good thing. I feel sorry for all the people who don’t have a job today, but in order to establish the credibility in the consumer’s mind as well as within industry FDA has to continue to do this sort of thing to get attention,” said Mark LeDoux, CEO of Natural Alternatives International.
History of noncompliance
GMP rules have now in place for all tiers of industry for a number of years. Enforcement for the largest companies phased in first; the smallest companies have had to be in compliance since July 2010. But Kabco is not one of these, and so should in theory have had four or more years’ worth of experience in GMP compliance. Kabco’s record seems to indicate a company that was not taking compliance seriously enough.
“I think it would be fair to say that it is the most recognizable and largest of the companies that FDA has gone after like this. This isn’t a fringe player.”
“There is not excuse for this sort of thing,” LeDoux said. “We’re a company that’s been doing this for a long time, and it’s kind of hard to compete with companies that don’t take this stuff seriously.”
The consent decree lays out a number of benchmarks Kabco must meet before resuming production. These include the hiring of independent quality control experts to both review the company’s plan for coming into compliance and to audit the company’s operations on a regular basis. There no way to judge at this point how long and expensive that process might be, but a safe bet is long and very. Attempts to reach Kabco officials for comment were unsuccessful.
Is industry getting the message?
Both Ullman and LeDoux said this should serve to put industry on notice about GMP compliance and enforcement, but it’s unclear how many companies are getting the message.
“This should be a wakeup call, yet, today, we see letters in which FDA is saying, you don’t have ANY manufacturing records,” Ullman said.
“I think what is alarming is we are seeing this kind of activity at the baseline of GMP compliance. We are still seeing (failures) at the MMR level.
“What’s going to happen when FDA says OK, let’s talk about the method you use for identity testing? Or let’s talk about what you use for your reference standard? FDA is just starting to get to that level,” he said.
“The FDA has been fairly transparent of what their objectives are. They want the industry to come into compliance with GMPs,” LeDoux said.