The FDA cited Kronner Prototypes for its complaint handling, reporting procedures and quality issues.
Following an April inspection of the devicemaker’s Roseburg, Ore., facility, the FDA issued a Form 483 noting the firm had three different, often contradictory, complaint handling procedures. Several complaints failed to include an evaluation of whether they should be reported to the FDA — and the company had no written MDR procedures.
The company also failed to document verification or validation of corrective actions taken in response to two complaints, and it did not properly implement procedures for measuring instrument calibration, the agency said. Other deficiencies included incomplete checklists for finished device acceptance.