Kabco Pharma Fighting for Its Life

Kabco Pharma Fighting for Its Life

April 8th, 2013 // 2:33 pm @

Exclusive FDA News and Compliance Tips

Contract manufacturer Kabco Pharmaceuticals must halt production of dietary supplements until it proves its facilities are in compliance with dietary supplement good manufacturing practices (GMPs), according to a consent decree signed by FDA and Kabco, and approved April 4 by Jospeh Bianco, a federal judge in the U.S. District Court of Eastern New York.

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FDA filed its initial complaint against Kabco and its owner Abu Kamir in July 2012 long after its 2010 warning letter tot he company over GMP violations found during FDA inspection of the company’s Amityville, NY facilities. The warning letter cited a litany of serious GMP violations, including failure to conduct testing and qualify suppliers, and create and maintain complete master manufacturing records (MMRs) and batch records; the letter also noted the company’s responses to the 483 report violations were inadequate.

As part of the new consent decree, Kabco must hire an independent expert to inspect the Kabco facilities for compliance with dietary supplement GMPs. After a comprehensive inspection, the expert auditor will issue a detailed report to FDA and would have to notify FDA of any corrective actions taken relative to violations found. The defendants must also communicate to FDA on any corrective actions taken.

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FDA can also inspect the facilities at any time, with or without notice, to further assess GMP compliance, and all inspections and related expenses under the decree would be paid by the defendants. After any such FDA inspection, the agency has 60 days to notify the defendants of apparent compliance, although the decree clearly states silence from FDA is not considered a notification of compliance.

In addition to these restrictions, Kabco must destroy, under FDA supervision, any supplements deemed adulterated. It must also retain the independent expert auditor, who must perform a GMP compliance inspection once every six months, reporting all findings and observations to FDA.

The costs of corrections, inspections and ongoing compliance, as well as lost revenue during injunction, are not the only potential financial blows to Kabco in this case. For any defendant found violating teh decree, penalties can include: a stop to manufacturing, forced recall and other corrective enforcement actions—all at the defendant’s expense—as well as a fine of $15,000 in liquid damages for each violation and $15,000 for each day a violation occurs; the violative defendant will also have to pay the sum of twice the value of any shipped supplement in violation. The decree  notes these penalties are not punitive and do not limit further penalties levied against a defendant that violates the decree.

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