FDA 483 - SoClean, Inc - February 06, 2023

SoClean, Inc. in Peterborough, NH, was inspected from January 24 to February 6, 2023, and received a Form FDA 483 with five observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for nonconforming product disposition, failure to identify product acceptance status, unperformed quality audits, and insufficient device history record procedures. Additionally, the firm failed to submit several Medical Device Reports within the mandatory 30-day timeframe.