483
Eyegaze Inc.FDA 483 - Eyegaze Inc. - October 08, 2021
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An FDA inspection of Eyegaze Inc., a medical device manufacturer in Fairfax, VA, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for complaint handling, document control, purchasing controls, quality audits, and employee training. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.
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