Remediation after a notified body audit, a 483 or a warning letter
I analyze the findings, build the corrective action plan and the evidence that supports it, and help you respond on time. For a 483 or a warning letter, I map the gaps and lead the remediation plan.
Three situations where this works best
Your certificate depends on closing them within the deadline.
The FDA investigator left observations, and the time to respond is short.
The FDA expects a response and a remediation plan that covers the whole system.
A notified body raised major findings
You received a 483
You received a warning letter
You have findings to answer, and the deadline is close.
Earlier responses were not accepted.
The same findings came back in the next audit.
You are not sure how far a finding reaches across the system.
Management needs a clear picture of the risk and the plan.
You probably need this if one of these sounds familiar
From the finding to a fix that holds
What it means, how far it reaches and what caused it.
Actions, owners and dates, with the evidence each one needs.
Clear answers to the notified body or the FDA, within the deadline.
Actions carried out and checked for effectiveness, so the findings don't return.
An analysis of every finding
A corrective action plan
A response on time
Follow-through
From a first conversation to the work itself
You tell me about the device, the market you are aiming for and your timelines. I tell you what I would do first.
When needed, I go through your procedures, your technical file or your most recent audit reports.
The scope of work, estimated hours and a timeline. I work by the hour.
I work with your team on what the company needs at that stage, and we meet regularly for updates.
A first conversation
Looking at what you have
A clear proposal
The work itself
In January 2023, a company came to me after a difficult stage 1 MDR audit. It had lost its CE certificate under the MDD and could not sell in Europe. We reviewed its processes, procedures and product files, improved the quality system, trained the team on the MDR requirements and prepared for the audit together. The stage 2 audit in May 2023 ended with no findings, and the CE certificate arrived in October 2023. The two surveillance audits that followed, in March and December 2024, also ended with no findings.
From a difficult stage 1 to zero findings
I analyze the findings, build the corrective action plan and the documentation that supports it, and help you respond on time. For a 483 or a warning letter, I map the gaps and lead the remediation plan.
Notified body audits, FDA inspections, MDSAP audits and customer audits. I prepare your team, run internal and mock audits, and support you during the audit itself.
It depends on the scope. I work by the hour, and after a first conversation, and sometimes a look at what you already have, I send a proposal with the scope, estimated hours and timeline.
What happens after an audit finding or an FDA warning letter?
What types of audits do you support?
How much does it cost?
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A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.