483
Alyk Inc.Alyk Inc. – FDA 483, May 20, 2022
Record Details
Alyk Inc., a medical device manufacturer and importer in New York, NY, was inspected by the FDA. The inspection revealed one observation concerning the firm's failure to maintain written Medical Device Reporting (MDR) procedures. Specifically, the firm lacked electronic MDR procedures and an Electronic Submissions Gateway account for reporting serious injuries and deaths.
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ID · 828f1e6b-3f32-481f-9aed-3bc00a57ff0c
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