Routine FDA Audit passed without non-conformities
On 15-17 July 2008 FDA performed a routine inspection to CMI covering FDA’s Quality System/Current Good Manufacturing Practice Regulations for Medical Devices (21 CFR Part 820). This audit was a part of FDA’s effort to inspect foreign manufacturers that export their products to the United States.
Previous audit to CMI was in 2004. CMI successfully passed the FDA inspection with no non-conformances and without the issuance of a form FDA 483, Inspectional Observations.
We are all pleased that our Quality Management System continues to meet or exceed the highest standards in the industry.