The FDA handed Ningbo Hecai Medical Equipment a Form 483 for failing to verify the effectiveness of a CAPA and other violations.
The Zhejiang, China-based company initiated a CAPA in 2017 over a nonconformance in an electric bed component. The facility made a change to its manufacturing operations but failed to verify its effectiveness, the agency said.
Additionally, the firm performed repairs on locally distributed devices that were documented, as required, on repair forms. However, it failed to send all forms to the quality department for evaluation.