483
ARCH Medical Solutions - WarsawARCH Medical Solutions - Warsaw – FDA 483, Dec 4, 2024
Record Details
An inspection of ARCH Medical Solutions - Warsaw revealed significant deficiencies in their quality system. The firm failed to adequately establish and follow procedures for controlling nonconforming product, including dispositioning, rework, and scrap. Additionally, acceptance activities were not consistently documented, and procedures for routine equipment calibration were found to be inadequate.
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ID · e2777c3c-6798-4e94-be6b-83ca7799ce30
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