483
Kinamed IncKinamed Inc – FDA 483, Feb 12, 2020
Record Details
Kinamed Inc., a medical device manufacturer in Camarillo, CA, was inspected by the FDA. The inspection revealed a significant issue with the firm's design control procedures, specifically regarding the inadequate documentation of design review results for a key product. This indicates a need for improved adherence to established quality system requirements for design history files.
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ID · ccbdf94a-3272-4496-b2d3-c89040d5bc69
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