The FDA hit Plano, Texas devicemaker Belluscura with a Form 483 for failing to properly document evaluations of potential suppliers to ensure that their products conformed to specified requirements.
In a Nov. 19-29, 2018 inspection, the agency noted that the facility evaluated prospective suppliers using a questionnaire prior to an audit but had failed to do that for two of its suppliers.
The firm also failed to document its supplier ratings on a Supplier Summary Rationale form as required by its quality procedures.
