FDA issues alert for Front Range Labs

LOVELAND – The U.S. Food and Drug Administration on Wednesday issued an advisory to pharmacists expressing concerns about the adequacy of testing perform at Loveland-based Front Range Laboratories Inc.

Front Range Labs serves as a testing laboratory for more than 100 pharmacies in 32 states to verify quality, sterility and expiration dating, according to a release from the FDA.

An FDA spokesman confirmed the alert Thursday.

“In a recent inspection, FDA investigators 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,” the release states.

The inspection “was not prompted by any inaccurate laboratory test results, safety concerns, serious adverse event reports or quality issues related to products tested by our lab for our compounding pharmacy clients,” according to a statement from Front Range Labs.

“We are not aware that any of our clients are registered with FDA as drug manufacturers, nor have we knowingly tested manufactured drug products,” the Front Range Labs statement said.

The statement also emphasizes that Front Range does not manufacture drugs, but instead serves as a testing sites for compounding pharmacies.

The FDA inspection that took place tested Front Range’s processes against the FDA’s “Current Good Manufacturing Practice,” regulations, which do not legally apply to compounding pharmacies unless they are acting as drug manufacturers, according to Front Range.

Front Range is working with the FDA to notify its customers and to determine if certain drugs should be removed from the market due to safety concerns, according to the release.

“We have voluntarily committed to certain changes in our operations that will address use of (Current Good Manufacturing Practice) in our testing operations,” Front Range said.

The FDA will update the public as new information becomes available, according to spokesperson Christopher Kelly. Front Range clients will receive a letter from the company addressing the findings of the inspection.

Front Range’s full statement can be found here.

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