483
CardioFocus, Inc.CardioFocus, Inc. – FDA 483, Aug 11, 2022
Record Details
CardioFocus, Inc. in Marlborough, MA, underwent an FDA inspection from August 8-11, 2022, resulting in three observations. The inspection revealed deficiencies in complaint handling procedures, including failure to close a significant number of complaints and inadequate procedures for Accidental Radiation Occurrences. Additionally, the firm failed to perform required qualifications for manufacturing equipment used in catheter production.
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ID · b85149ad-7a4d-49eb-8fd8-246799816cb4
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