FDA Warns Oregon Company After CGMP Violations Found at Manufacturing Facility

A warning letter, dated Oct. 13, 2017, details current good manufacturing practice (CGMP) violations found during an FDA inspection of the Salem, OR facility of Ridge Properties, LLC dba Pain Relief Naturally. The violations ranged from failure to test products for identity and strength to producing unapproved and misbranded drugs.

The FDA inspection was conducted from Feb. 28, 2017 to March 16, 2017. Investigators observed that the company was not performing appropriate laboratory testing on its products before distributing the products; products were not tested for chemical or microbial attributes.

The company also failed to establish an adequate quality control unit or quality procedures. “During the inspection, we found that your firm lacked critical procedures to ensure a functional quality unit including, but not limited to, procedures for establishing specifications and complaint handling,” the agency stated in the letter. The company also failed to separate areas to prevent contamination.

“Your firm manufactures drug products in a kitchen. 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,” the letter stated.

In addition, some of the products manufactured by the company were found by FDA to be either unapproved or misbranded. Products determined to be unapproved or misbranded drugs included Extra Strength Naturally HL Hemorrhoid Numbing With Lidocaine and Extra Strength PreTAT Gel With Added Lidocaine.

FDA recommended the company obtain a CGMP consultant to resolve the violations and stated: “Correct the violations cited in this letter promptly. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts.”

Source: FDA