Regulatory Focus™ > News Articles > Inspection of Contract Testing Lab Raises Product Quality Questions for Dozens of Companies

Inspection of Contract Testing Lab Raises Product Quality Questions for Dozens of Companies

Posted 22 August 2013 | By Alexander Gaffney, RAC 

Pharmaceutical compounding operations have gotten something of a bad reputation of late. Thanks to a massive outbreak of meningitis caused by deficient compounding practices and dozens of inspections by the US Food and Drug Administration (FDA) that have found rampant sterility issues, many legislators, insurers and physicians are now taking a close and critical look at the compounding industry.

In response, some compounders have instituted (or have long instituted) measures to provide assurance of the sterility of their products by utilizing the services of third-party testing laboratories. But now FDA has issued a warning about one of these testing laboratories, saying a Colorado facility used by more than 100 pharmacies across the US used deficient sterility testing practices.

The company in question is Front Range Laboratories, Inc, a Loveland, CO-based testing lab that caters exclusively to compounding pharmacies and verifies the quality, sterility and expiration dating of products.

The problem, FDA said in a statement, is that when agency regulators inspected the company's facility, they "observed that methods used by Front Range to assess sterility and other qualities (e.g. strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results."

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

FDA added that it is now working with the company to notify customers and assess the need for a recall if any products have safety concerns.

The scale and scope of Front Range's operations has the potential to result in a large number of recalls. FDA noted that it is used by more than 100 companies across 32 states in the US. FDA also recently noted that it is inspecting contract testing laboratories as part of its regular inspection practices. In an August 2013 letter to Texas-based NuVision pharmacy, FDA said an inspection of an unnamed contract testing facility had determined that one of NuVision's products had failed its sterility test.

Between both Front Range and the unnamed laboratory-possibly the same one-the development could mean FDA is now beginning to target contract testing laboratories, a development which could serve to amplify uncertainty about product quality in the future.


FDA Statement on Front Range


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