FDA 483 - BTI Filtration - May 11, 2023
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An FDA inspection of BTI Filtration, a manufacturer in Oklahoma City, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for the acceptance of incoming raw materials and did not maintain corresponding acceptance or rejection records. Additionally, procedures for ensuring purchased products and services conform to specified requirements, including supplier evaluation and re-evaluation, were found to be inadequate.
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