FDA 483 - EMIT Corporation - March 07, 2023
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An FDA inspection of EMIT Corporation, a medical device manufacturer in Houston, TX, revealed significant deficiencies in its complaint investigation records. The firm failed to document required information for device clinical incidents, including details of complaints, reportability assessments, and product history reviews. Additionally, the company's complaint handling procedures lacked provisions for capturing and documenting Unique Device Identification (UDI) information.
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