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A July inspection resulted in these conclusions.
February 6, 2009
By: Editor
The FDA has cited rehabilitation equipment manufacturer Pneumex in a December warning. These conclusions are based on a July inspection at the Idaho plant:
• Failure to implement design and development plans for the Vibro-Trac table
• Failure to document or approve design input requirements for the Vibro-Trac table
• Failure to maintain production records on the Pneu-Back Chair since 2004
• Failure to perform “quality audits” on any devices since 2004
• Failure to designate an individual to review and approve documents
See the warning letter at compliancefda.com/ShowExternHTML.aspF=CFDAs7061c&src=RSS.
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