FDA Warns Canadian Firm Over cGMP Deviations

March 25, 2005

The FDA has issued a warning letter to Canadian drugmaker Germiphene after an inspection of the company's Brantford, Ontario, plant revealed significant deviations from current good manufacturing practices (cGMPs).

The warning letter described a wide range of manufacturing violations at the Brantford plant, which manufactures dental drugs and other pharmaceutical products. The inspection was conducted Oct. 12-15, 2004.

Among the major deficiencies was the presence of employees who were not adequately trained to perform their assigned manufacturing functions. For example, many Germiphene workers could not answer questions about equipment they were reportedly trained to use, the FDA said.

Germiphene was also cited for failing to properly calibrate its manufacturing equipment. The FDA investigators found three instruments out of calibration, one of which had been out of calibration for five months. The agency also found fault with Germiphene's laboratory equipment, citing the company for using equipment in a different manner than that for which it was qualified.

In addition to the cGMP problems, the FDA said several Germiphene products had inaccurate labeling. To view the warning letter, go to http://www.fda.gov/cder/warn/2005/320-05-01.pdf (http://www.fda.gov/cder/warn/2005/320-05-01.pdf).