483
SINO MEDICAL SCIENCES TECHNOLOGY INCSINO MEDICAL SCIENCES TECHNOLOGY INC – FDA 483, Aug 24, 2023
Record Details
An FDA inspection of SINO MEDICAL SCIENCES TECHNOLOGY INC, a medical device manufacturer in Tianjin, China, revealed three significant observations. The firm was cited for inadequate establishment and implementation of procedures for corrective and preventive actions, as well as deficiencies in developing and maintaining written Medical Device Reporting (MDR) procedures. Additionally, the inspection found that procedures for design validation had not been fully implemented.
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ID · 74b56af8-a607-4f2a-948c-625a379b3af7
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