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Home » Inadequate Responses to Form 483 Observations Lands MicroVention a Warning Letter
Inadequate Responses to Form 483 Observations Lands MicroVention a Warning Letter
The FDA has sent neurovascular device company MicroVention a warning letter after the agency was not satisfied with the company’s responses to a Form 483 inspection report which noted problems with validations, correction and preventive actions, and other lapses.