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Precision Ear Mold Labs, ,Altamonte Springs, FL.
- Article from:
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Warning Letter Bulletin
- Article date:
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September 27, 1999
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Copyright informationCOPYRIGHT 1999 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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Precision Ear Mold Labs, ,Altamonte Springs, FL, Sept. 7 (Office of Compliance). FDA cited deviations in the manufacture and repair of hearing aids, including failure to analyze all sources of quality data to identify the causes of product non-conformities; a lack of procedures for internal audits and CAPA; inadequate finished device testing procedures, since only 20 of 16,000 Crystal Ear devices were tested and results ...