The Salem, Oregon-based firm significantly violated current good manufacturing practice (cGMP) regulations for finished pharmaceuticals, according to a warning letter sent by the US Food and Drug Administration (FDA) last month.
According to the Agency, Ridge Properties DBA Pain Relief Naturally makes topical analgesic drug products for treating bleeding wounds, bedsores, and tattoo procedure pain but failed to test its products for attributes including identity and strength of each active ingredient before distributing batches.
The FDA, which inspected the facility in February and March, also accused the firm of manufacturing drug products “in a kitchen,” as part of its contamination and mix-up concerns.
“You use household kitchen utensils and cookware, including a steel pot, (b)(4) blender, and kitchen spatula to mix ingredients. Our investigator observed conditions and practices that increase the risk of your drug products containing harmful and insanitary contaminants.”
“For example, you had a window open to the outside for ventilation during production. You also stored cleaning equipment near formulation ingredients without adequate controls to prevent contamination.”
Ridge Properties was also found to have not adequately investigated more than 50 complaints made against its 4% lidocaine TAT Balm products for “ineffectiveness” and “inadequate numbing strength,” and for misbranding several of its drug products.
Just after two weeks after receiving the letter, Ridge Properties voluntarily recalled all lots of Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, made from the facility.
The reason given was due to: “Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process in decreased quality and consistency (i.e., the safety, identity, strength, quality and purity).”