The FDA called out American Thermal Instruments, a devicemaker based in Moraine, Ohio, for failing to evaluate suppliers and receive notifications of product changes, in addition to having device master record problems.
The agency’s February inspection revealed that the firm did not complete evaluations of potential suppliers and contractors. The company lacked agreements between suppliers and contractors that ensured notifications of any changes in products or services.
The firm also had device master records that were not properly maintained. The work instructions contained in two device master records were incorrect and the company did not maintain its electronic device master records as instructed by its procedure.