Nevada Devicemaker Hit for Missing Design Control Procedures
The FDA cited devicemaker Steiner Biotechnology after finding the company lacked design control procedures for one of its products.
In a Dec. 10-13, 2018 inspection of the firm’s Henderson, Nevada facility, the agency found it lacked design control procedures for its Oral Bond Dental Adhesive device. Steiner had no records showing it established design plans and inputs before releasing the product for distribution.
The investigator also noted the firm had no records demonstrating the firm validated the device’s design, conducted design reviews or transitioned the design into its production specifications.