When this service applies
The work begins after receipt of an infraction notice, official report, notice, or other document that requires a response and has technical content related to the operation.
Because deadlines can be short, the first step is to record the date of receipt, preserve the existing documents, and identify which areas need to take part in the analysis.
What we do first
We start with the document received.
We separate each finding, identify the facts mentioned, and gather the procedures, records, owners, and evidence related to each item.
We also record what has already been corrected since the inspection and what still requires action.
What we analyze
Depending on the case, the analysis may involve:
- Documents presented during the inspection
- Procedures in effect on the date of the event
- Process records
- Training
- Deviations and investigations
- CAPAs
- Internal communications
- Supplier contracts and records
- Photographs or evidence preserved by the company
- Actions taken after the inspection
Each finding needs to be addressed separately
An infraction notice may combine different topics in the same document.
Separating the items avoids generic responses and makes it possible to show, for each finding, what the situation was, what records exist, what has been corrected, and which actions remain open.
Technical correction starts even while the response is still being prepared
If the analysis finds a problem that is still occurring, the company does not need to wait until the response is fully drafted to start containment or the appropriate correction.
The measures taken are recorded with date, owner, and evidence. We do not create or backdate records to fill past gaps.
What Intelilab delivers
Depending on the scope, we can prepare:
- Technical breakdown of the findings
- Chronology of events
- List of available evidence
- Identification of documentation gaps
- Cause analysis
- CAPA and action plan
- Description of corrections already made
- Technical dossier to support the company's response
Technical and legal matters are handled separately
Intelilab works on reconstructing the facts, technical analysis, evidence, cause investigation, and corrective actions.
Issues such as nullity, the authority's jurisdiction, statute of limitations, appeal strategy, penalty calculation, or litigation should be handled by the company's legal counsel.
When necessary, the technical material can be organized for joint use with an attorney or legal counsel.
The deadline depends on the document and the responsible authority
The company should immediately check the deadline stated in the proceeding or in the document received.
Intelilab organizes the technical work within the stated deadline, but does not assume that all proceedings follow the same procedure.
An infraction notice can reveal a larger problem than the isolated event
Sometimes the citation is related to a process that already had recurring failures, such as training, document control, supplier management or CAPA.
In that case, the technical work may identify the need for a broader process review, separate from the immediate response.
What this service does not do
We do not promise cancellation of the infraction notice, reduction of penalties or any specific outcome in the proceeding.
We also do not replace legal representation when it is required.
Frequently asked questions
Can you write the entire response?
We can structure and draft the technical part defined in the scope. The legal part should be reviewed or prepared by the legal representative when necessary.
Is it possible to correct documents after the inspection?
It is possible to review and correct processes going forward, with proper recording of the change. We do not create backdated documents as if they existed on the date of the inspection.
What do I need to send first?
The document received, the date of notification and the materials directly related to the findings are the most useful starting point.
Have you received an infraction notice or another type of notice?
Send the document received and tell us the date of notification so we can assess the technical scope required.