483
EXACT MEDICAL MANUFACTURINGFDA 483 - EXACT MEDICAL MANUFACTURING - May 02, 2019
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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