483
Fundus Photo, LLCFundus Photo, LLC – FDA 483, Apr 12, 2022
Record Details
An FDA inspection of Fundus Photo, LLC, a medical device manufacturer in Saint Louis, MO, from April 7-12, 2022, identified one significant observation. The firm failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures. This indicates a deficiency in their quality system regarding adverse event reporting.
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ID · 96cbd9bc-5fe7-4eaa-84a8-446321f60cc4
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