FDA 483 - NovoSci Corporation - November 07, 2019

Novateci Corporation, a medical device manufacturer in Conroe, TX, was cited for significant deficiencies across its quality system during an FDA inspection. Issues included inadequate quality audits, failure to maintain Device Master Records, poorly established process validation and environmental control procedures, and a failure to properly implement Medical Device Reporting procedures. These findings indicate systemic quality control failures that could impact product quality and patient safety.