Rehab Devicemaker Warned for Seven GMP Violations

Failure to implement plans and approve design input requirements and other alleged good manufacturing practice (GMP) violations have resulted in a warning letter for rehabilitation equipment manufacturer Pneumex. Based on an inspection last July of the Idaho plant, the FDA cited the company for not performing quality audits since 2004 for all products and not implementing existing design and development plans for its Vibro-Trac table.
The GMP Letter