483
Healthlight LLCFDA 483 - Healthlight LLC - March 11, 2021
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Record Details
An FDA inspection of Healthlight LLC, a medical device manufacturer in Schaumburg, IL, revealed a significant deficiency related to their quality system. The firm was cited for failing to establish written procedures for Medical Device Reporting (MDR). This indicates a fundamental gap in their regulatory compliance for post-market surveillance.
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