Regulatory Focus™ > News Articles > Fallout from Deficient Testing Contractor Begins as Three Firms Issue Recalls

Fallout from Deficient Testing Contractor Begins as Three Firms Issue Recalls

Posted 28 August 2013 | By Alexander Gaffney, RAC 

US regulators have facilitated three nationwide voluntary recalls for pharmaceutical products manufactured by compounding pharmacies so far this week, the fallout of earlier deficiency findings at a contract testing laboratory that provided sterility assurance testing for hundreds of pharmacies across the US.

Background

In August 2013, FDA issued a statement that Loveland, CO-based Front Range Laboratories, Inc. had been observed to be using deficient methods to assess the sterility, strength and stability of products brought to it for testing.

"FDA has concerns that results obtained from Front Range are not reliable," FDA said in a statement. "FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."

Unlike previous inspections, which focused on just a single company's products, Front Range's activities potentially affected more than 100 pharmacies across 32 US states, whose products could likely be found in all 50 states.

Three Firms Affected

FDA said it was working with Front Range to identify if any products needed to be recalled, and now those recall notices are starting to emerge, with three issued thus far.

Notices issued by Park Pharmacy & Compounding Center, Wellness Pharmacy Inc, and JCB Laboratories all referenced the Front Range inspection either explicitly or implicitly.

"This recall was initiated after Wellness Pharmacy was notified that in a recent inspection of Front Range Labs … may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on these lots," Wellness Pharmacy wrote in its recall statement. "FDA has concerns that test results obtained from Front Range Labs may not be reliable."

The good news is that while the recall has so far affected several companies, the actual products recalled have been relatively few. Park Pharmacy is recalling just two lots, while Wellness and JCB are recalling six lots each.

None of the companies reported having been made aware of any adverse events.


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