FDA Inspections

Over our 16 year history we have undergone 8 FDA inspections onsite and supported numerous clients during their FDA inspections. The inspection classifications ranged from general compliance, PAI, to special initiatives for 21 CFR Part 11. In January 2005 QTI underwent it’s 3rd FDA inspection in 4 years. The inspection was initiated as a High Complexity assignment by the FDA and resulted in no FDA 483s being issued. QTI currently performs over 900 regulated projects per year and is considered a GMP facility in good standing with the FDA.

Date	FDA Inspection Type
3/28/95	General Compliance
11/15/95	General Compliance
6/3/98	General Compliance
10/1/98	PAI
4/19/00	General Compliance/ PAI
7/10/01	General Compliance
4/18/03	General Compliance
1/11/05	General Compliance