FDA 483 - Standard Textile Co Inc - February 28, 2020

An FDA inspection of Standard Textile Co Inc, a medical device specification developer in Cincinnati, OH, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, including validation of such actions and related software. Additionally, procedures for rework of nonconforming products were not defined, and critical quality system documents were not readily available at all necessary locations.