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Medical Devices / Inspections and Audits

Belluscura Scolded for Supplier Evaluations

March 12, 2019
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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.

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