FDA WARNING_LETTER - William C. Domb, D.M.D., A Professional Corporation - March 20, 2012

This FDA Warning Letter, dated October 25, 2012, addresses William C. Domb, DMD A Professional Corporation, following inspections from February 16 to March 20, 2012, and attendance at a course on July 6-7, 2012. The firm manufactures Ozone Generating System devices, classified as medical devices.

The devices are adulterated because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded for failure to submit a 510(k) premarket notification.

Furthermore, the devices are adulterated under 21 CFR Part 820 (Quality System regulation) due to numerous manufacturing deficiencies. These include: 1. Failure to establish design control procedures (21 CFR 820.30). 2. Failure to validate device design, including risk analysis, specifically regarding ozone levels (21 CFR 820.30(g)). 3. Absence of corrective and preventive action procedures (21 CFR 820.100(a)). 4. Lack of procedures for purchasing controls and supplier evaluation (21 CFR 820.50). 5. Failure to establish complaint handling procedures (21 CFR 820.198(a)). 6. Absence of acceptance activity procedures for components and devices (21 CFR