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Article: Documentation and audit lapses noted at American Orthodontics.(MEDICAL DEVICES)
- Article from:
- Inspection Monitor
- Article date:
- October 1, 2008
CopyrightCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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American Orthodontics, Sheboygan, WI, Detroit District
American Orthodontics, a manufacturer of Class I and II orthodontic devices, was cited for failures in documenting CAPA and maintenance, conducting quality audits and appropriately reporting MDRs to FDA.
Investigator Kimberly Lewandowski-Walker conducted the inspection Feb. 12-16, 2007, and observed that the company had not documented the effectiveness of manufacturing change notices to ensure that the corrective actions did not adversely affect the finished device. She also noted in a separate observation that maintenance activities had not been documented for a laser system used in manufacturing ...
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