Wheelchair Maker Permobil Fails to Establish Adequate CAPA

Failure to implement corrective and preventive actions and to control nonconforming product landed wheelchair maker Permobil a 483 following a January inspection of the company’s Lebanon, Tennessee, plant.

The company apparently held a meeting in September 2017 to open a CAPA, but it was not actually opened until January 2018.

The FDA also said the firm’s non-conforming product procedure was inadequate in that it didn’t ensure investigations were adequately completed or documented.