How to Handle Your First Regulatory Inspection or Query
The outcome of a regulatory query is largely determined before it arrives, by whether your records exist. What you do on the day matters less than whether you can produce what is asked for. Here is how to handle both parts.
What Determines the Outcome
This guide is for supplement, Ayurvedic and herbal brand owners in India.
A query or inspection asks whether your product and its documentation are what they should be. If your licences are current and in scope, your artwork was compliance reviewed, your stability data covers your pack, your certificates of analysis exist per batch and your claims match an approved set, the process is largely administrative.
If those things are absent, the process is not administrative and nothing done on the day will change that. This is why the preparation described throughout product file maintenance is the actual answer to this question.
What the day itself determines is tone and cooperation, which matter, and whether you say something unhelpful while improvising.
Immediate Steps
On receiving a query or notice.
- Read it carefully and identify exactly what is being asked and by when.
- Involve a qualified professional immediately, before responding substantively.
- Acknowledge receipt within any stated timeframe, which is usually appropriate and does not require answering the substance.
- Identify which product, batch or listing the query concerns.
- Retrieve the relevant product file and check it is complete.
- Identify any gap in what is being asked for, so your adviser knows the position.
- Do not alter, backdate or create documents. This converts a compliance question into a far more serious matter.
- Do not destroy anything.
- Nominate one person to handle correspondence, so responses are consistent.
- Keep a record of everything provided and every communication.
What to Provide
Generally, what is asked for, accurately and completely.
| Commonly Requested | Where It Should Be |
|---|---|
| Your registration or licence | Product file, regulatory section |
| Manufacturer’s licence with scope | Product file, regulatory section |
| Product specification | Product file, product section |
| Certificates of analysis by batch | Product file, evidence section |
| Stability data for the pack | Product file, evidence section |
| Label artwork and review record | Product file, product section |
| Batch and dispatch records | Your inventory records |
| Complaint records | Your complaint log |
| Supplier and input documentation | Product file, or from your manufacturer |
Provide what is asked rather than volunteering additional material beyond it, and take your adviser’s guidance on scope. Completeness and accuracy matter more than volume.
What Not to Do
Five responses that make things worse.
Improvising Answers
Speculating about a technical or regulatory point you are unsure of creates a record of something inaccurate. Say you will confirm and come back.
Altering Documents
Changing, backdating or creating documents is a far more serious matter than whatever the original query concerned.
Being Obstructive
Cooperation is both appropriate and in your interest. Delay and evasion worsen the position.
Multiple People Responding
Inconsistent answers from different people create confusion that reads as something worse.
Ignoring Timeframes
Missing a stated deadline is avoidable and is held against you. Acknowledge promptly even where the substance takes longer.
The first is the most common. There is no disadvantage in saying that you will confirm a detail and respond, and considerable disadvantage in guessing.
Afterwards
Whatever the outcome, use it.
Record what was asked, what you provided and where the gaps were. Those gaps are your preparation list for next time, and they are usually the same gaps a buyer’s audit would find.
Then close them: the missing stability data, the artwork review record that was never kept, the certificates that were filed unread, the batch dispatch records that did not exist. Each is a fixable records problem.
And take your adviser’s guidance on any corrective action required, implementing it fully rather than partially, since a repeated issue is treated differently from a first one.
Checklist
Preparation and response.
- Maintain a complete product file per SKU before anything arrives.
- Keep licences and certificates current and in scope.
- Keep artwork compliance review records.
- Keep certificates of analysis per batch, checked.
- Keep batch dispatch records.
- Keep a complaint log with batch numbers.
- Identify in advance the professional you will call.
- On a query, involve them before responding substantively.
- Acknowledge receipt within any stated timeframe.
- Nominate one person for correspondence.
- Provide what is asked, accurately and completely.
- Never alter, backdate or create documents.
- Say you will confirm rather than improvising answers.
- Record everything provided and all communications.
- Close the gaps the query revealed.
- Implement any corrective action fully.
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Frequently Asked Questions
What determines the outcome of a regulatory query?
Largely whether your records exist before it arrives: current in-scope licences, compliance-reviewed artwork, stability data for your pack, certificates of analysis per batch, and claims matching an approved set. Nothing done on the day substitutes for those.
What is the first step on receiving one?
Involve a qualified professional immediately, before responding substantively. Acknowledge receipt within any stated timeframe, which is appropriate and does not require answering the substance.
What should I provide?
What is asked for, accurately and completely, taking your adviser’s guidance on scope rather than volunteering additional material. Completeness and accuracy matter more than volume.
What is the most common mistake?
Improvising answers to technical or regulatory points you are unsure of, which creates a record of something inaccurate. There is no disadvantage in saying you will confirm and respond, and considerable disadvantage in guessing.
What should never be done?
Altering, backdating or creating documents, which converts a compliance question into a far more serious matter. Also avoid obstruction, inconsistent responses from multiple people, and missing stated deadlines.