FDA 483 - Flex-Cell Precision, Inc - February 03, 2023

Flex-Cell Precision, Inc. in Lancaster, PA, was inspected by the FDA from February 1-3, 2023. The inspection revealed a significant issue regarding the firm's quality audit practices, specifically a failure to ensure auditor independence. This deficiency was noted across multiple audit areas and years, indicating a systemic problem that could lead to ineffective audits.