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483
•Lumanosity Inc•August 24, 2018

Lumanosity Inc – FDA 483, Aug 24, 2018

Record Details

Lumanosity Inc, a medical device manufacturer in San Diego, CA, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed a lack of established procedures for design control and device history records for their Class II Infrared Light Therapy medical device.

Company
Lumanosity Inc
Inspection date
August 24, 2018
Product type
device
Office
Division of Pharmaceutical Quality Operations IV
Person
  • Sarah A. Hassas (investigator)
View Company Profile

ID · 5d6449d2-c611-4861-9fcd-4e115ac28536

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