483
Johnson Medtech LLCFDA 483 - Johnson Medtech LLC - November 27, 2023
Record Details
Johnson Medtech LLC, a medical device manufacturer in Vandalia, OH, received a Form FDA 483 with four repeat observations. The inspection revealed significant deficiencies in process validation, production process control, corrective and preventive action procedures, and product acceptance status. These issues indicate a systemic lack of adherence to quality system requirements, posing potential risks to device quality and patient safety.
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ID · a1a30be7-8fb4-4b8a-8360-f9d2bfa09d70