FDA 483 Action Planning & Remediation

An early stage device company received a 483 with multiple observations after a long two-week BIMO inspection and were in need of strategic support to address findings in a short period of time and develop an action plan for remediation.

Warning Letter Remediation

A global medical device company received repeat 483s and a Warning letter from the FDA. Halloran provided immediate expert regulatory and quality leadership overseeing interactions with the agency, remediation, and correction of 50+ findings.

FDA reporting tool

Device manufacturers beware!  FDA recently released a reporting tool to supplement their compliance oversight resources.  Through FDA’s website, anyone can complete and submit a form to report allegations of regulatory misconduct.
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