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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.

I’d like to take a moment to express my gratitude for AlvaMed’s quick response, experience and professional approach to addressing our efforts to respond to an audit finding. AlvaMed conducted a comprehensive assessment of our product technical documentation, identified gaps related to current standards and regulations, and provided a clear definition of objectives and a plan to address the gaps.

I am thoroughly satisfied with the level of expertise and diligence displayed by AlvaMed throughout this process. Without hesitation, I would highly recommend them to any medical device company seeking a consulting company to address compliance concerns.

Erik Williams

Anika

Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.

President

MedTech Client

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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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.

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