483
Ingen Orthopedics LLCIngen Orthopedics LLC – FDA 483, May 3, 2023
Record Details
An FDA inspection of Ingen Orthopedics LLC in Cranbury, NJ, a specification developer, revealed significant deficiencies in their quality system. The firm failed to adequately establish training procedures for field representatives, which led to a complaint involving the use of an expired device. Additionally, several critical procedures lacked documented approval dates, indicating poor document control.
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ID · df94deeb-098c-462d-9207-e0ce2c536574
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