Warning Letter: Germiphene

The US Food And Drug Administration (Rockville, MD, www.fda.gov) this week released a warning letter to Germiphene Corp. (Brantford, Ontario, Canada, www.germiphene.com), citing significant deviations from US Current Good Manufacturing Practice regulations.

The five-page letter to Germiphene, dated Feb. 15, stated that employees at the inspected manufacturing facility lacked the education and training required to perform their assigned functions, and that the laboratory facilities and equipment used for testing and approval or rejection of components and drug products were found to be inadequate. Other violations included the use of instruments/apparatus not meeting established specifications, and an inadequate stability testing program.

In addition, Germiphene's labeling was found to be "seriously deficient for marketing the products in the United States." The products were therefore misbranded, and in some cases unapproved new drugs, including the company's fluoride products, Denti-Care oral rinse products, and over-the-counter healthcare products, which were found to contain an non-FDA approved combination of tetracaine and benzocaine.

In the letter, FDA recommended the disapproval of any new applications listing Germiphene as manufacturer until the deficiencies observed have been corrected.

In a statement to Pharmaceutical Technology the drug manufacturer said, "Germiphene Corp. takes the FDA comments very seriously and is addressing their concerns. We believe the issue will be concluded shortly."

–George Koroneos