483
NEW LIFE DIAGNOSTICS LLCFDA 483 - NEW LIFE DIAGNOSTICS LLC - February 27, 2019
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Record Details
NEW LIFE DIAGNOSTICS LLC, a medical device manufacturer in Carlsbad, CA, was inspected from February 25-27, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate process controls, equipment calibration, acceptance activity documentation, purchasing controls, and complaint handling procedures. These issues indicate a broad lack of established and followed quality system procedures.
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ID · 224c8ff8-bb6d-4f89-8bcb-e988495a744b