483
EXACT MEDICAL MANUFACTURING, INC.EXACT MEDICAL MANUFACTURING, INC. – FDA 483, May 2, 2019
Record Details
EXACT MEDICAL MANUFACTURING in Changzhou, China, was inspected by the FDA from April 29 to May 2, 2019. The inspection revealed significant deficiencies in process validation, equipment calibration, and document control. These issues indicate a lack of adequate quality system procedures for manufacturing medical devices.
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ID · 692eece4-36d7-4f8f-84a0-82b277c8c312
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