483
Medtronic Puerto Rico Operations Co.FDA 483 - Medtronic Puerto Rico Operations Co. - February 21, 2019
Record Details
An FDA inspection of Medtronic Puerto Rico Operations Co., a medical device manufacturer in Juncos, PR, revealed significant deficiencies in its quality system. The firm failed to establish timely corrective and preventive action procedures and did not adequately investigate complaints involving potential device failures. These issues indicate a lack of robust quality control processes for medical devices.
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ID · b8afb54c-6a6f-42e6-8d69-3c3bb84898c1