Home » Wheelchair Maker Permobil Fails to Establish Adequate CAPA
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.
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