www.fdanews.com/articles/134402-inadequate-procedures-lead-to-first-warning-for-gunnell
Inadequate Procedures Lead to First Warning for Gunnell
February 18, 2011
Wheelchair manufacturer Gunnell is working with the FDA to clear up its first warning letter.
The Millington, Mich., company, which has been in business since the 1950s, failed to get approval or clearance for some of its products, and several of its manufacturing procedures are inadequate, according to a Nov. 9 warning letter posted last month.
As a result of the June inspection, the company is working on documentation issues and implementation of revised procedures, a Gunnell spokesman said.
The GMP Letter