FDA WARNING_LETTER - Advanced Orthogonal Equipment, Inc. - August 18, 2011

On August 18, 2011, an FDA inspection of Advanced Orthogonal Equipment, Inc. in Saint Petersburg, Florida, revealed that their Advanced Orthogonal Percussion Adjusting Instrument, a medical device, was adulterated and misbranded.

The device was adulterated under Section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Violations included: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). 2. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)). 3. Failure to establish and maintain adequate complaint handling procedures and designate a unit for these activities (21 CFR 820.198(a)). 4. Failure to establish and maintain procedures to ensure purchased products and services conform to requirements (21 CFR 820.50). 5. Failure to establish and maintain quality audit procedures and conduct audits (21 CFR 820.22).

The device was also misbranded under Section 502(t)(2) for failing to develop, maintain, and implement Medical Device Reporting (MDR) procedures (21 CFR 803.17).

Furthermore, the device was adulterated under Section 50