Remediation/Response – Inspection Findings

Strategies for effectively handling third-party audit/inspection findings

There is a lot to consider when responding to a nonconformity from a third-party audit/inspection. It’s not only what to say but what not to say. Navigating this can often be a challenge to manufacturers who want to provide an acceptable response while ensuring their efforts can be accomplished. Working with experienced professionals is one way to get the help needed and gain trust with regulators.

Gaining a full understanding of the reason(s) for the nonconformity and the situation that lead to it.

Gather the appropriate information needed to corroborate the nonconformity and interview the personnel involved.

Create a plan with measurable and obtainable goals, including the assignment of tasks and personnel.

Initiate all workstreams to progress toward meeting established timelines and track their status.

Ensure responses are provided on-time showing control of the situation and a commitment to correct and improve.

AlvaMed can provide a path toward regaining compliance.

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Remediation/Response – Inspection Findings FAQ's

No, only written nonconformities require a formal response, but it is advisable that verbal comments are considered for process improvements and preventive actions.

Failure to respond to an FDA 483 can result in fines, sanctions, suspension of operations, and other penalties.

Organizations can dispute a 483, but that does not absolve them of the requirement to provide data, backed by demonstrable, scientific facts.

Brian Ludovico

Director of Quality Affairs

Ready to learn more about how AlvaMed can assist you in responding to Inspection Findings?

Schedule time to meet with Brian Ludovico.