483
POM Medical LLCPOM Medical LLC – FDA 483, Mar 8, 2022
Record Details
POM Medical, LLC, a medical device manufacturer in Moorpark, CA, was inspected and cited for inadequate procedures to control non-conforming products. The inspection revealed failures in documenting material review board activities, completing non-conforming product forms, and documenting rework activities. These issues indicate deficiencies in the firm's quality system for managing products that do not meet specified requirements.
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ID · 8848f21f-945b-40fc-aff1-39ca3f7c4d2c
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