Permobil IncJanuary 11, 2018

FDA 483 - Permobil Inc - January 11, 2018

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Permobil Inc

Record Details

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.

Company: Permobil Inc
Inspection Date: January 11, 2018
Product Type: Device
Office: New Orleans District Office
Person: Mary A. Millner

Open in Dashboard

ID · f78395f4-6aa3-4837-91e8-104dc0db112f