483
Permobil IncPermobil Inc – FDA 483, Jan 11, 2018
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.
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ID · f78395f4-6aa3-4837-91e8-104dc0db112f
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