# FDA 483 - Permobil Inc - January 11, 2018

Source: https://www.keypedia.com/records/483/permobil-inc/f78395f4-6aa3-4837-91e8-104dc0db112f

> FDA 483 for Permobil Inc on January 11, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Permobil Inc
- Inspection Date: 2018-01-11
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Permobil Inc. in Lebanon, TN, a manufacturer, revealed two significant observations. The firm failed to adequately establish and implement procedures for corrective and preventive actions, including delays in opening CAPAs and improper approvals. Additionally, procedures for controlling non-conforming products were found to be inadequate, with issues in investigation, documentation of disposition, and rework activities.

## Related Officers

- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.keypedia.com/companies/permobil-inc/61d4e282-3d2e-4264-a233-860e885f4716

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea