Halloran Consulting Group — a consulting group specializing in life sciences — regularly has conversations with potential clients that begin like this: We just got the call from the FDA, and they’re coming for an inspection. Can you put everyone on a flight to help us get ready? While this might be a great opportunity for the Halloran team, it’s costly and produces stress that an organization doesn’t need. Inspections can occur in any company at any time. The outcome, when positive, can be an incredibly valuable exercise, provided the company has a solid plan, supported by an experienced team.
To get your company started with proactive preparation (and avoid that call of panic), here is a list of dos and don’ts.
- Be prepared to show the process or SOP to which your work is tied.
- ONLY answer questions related to your position and study role.
- Answer only questions you know the answer to. “I don’t know, but I will follow up,” is a perfectly acceptable response.
- Restrict conversations in common areas.
- Answer questions politely, truthfully, directly, and to the point.
- Know your job responsibilities, based on your job description.
- Refer to pertinent documentation when possible.
- Ensure you understand any questions before answering.
- Volunteer additional information.
- Lie or deny the obvious.
- Promise things you are not sure you can deliver.
- Provide direct access to any electronic systems — not even “read-only” access.
- Allow the FDA Inspectors to freely: 1) look through documents, 2) walk through the facility unescorted, or 3) take photos or videos.
- Provide audit reports of sites and vendors, personnel records, or financial information.
- Comment on quality or admit non-compliance.
- Read or sign statements or affidavits.
- Argue with the FDA or your peers.
- Forge someone else’s signature.
- Recopy documents just to make them neat or impress the FDA or management.
- Fabricate documents.
- Assume anything when dealing with the FDA inspector.
Some of this advice may seem obvious, but Halloran has seen it all, and people don’t always act rationally when they’re under immense amounts of pressure. It’s important that you discuss matters with your team well in advance to avoid any slip ups.
If you have any questions, please give Halloran a call or check out their website. And remember, an inspection isn’t life or death. Poor responses can have far-reaching implications for your company and the product you have worked hard to get to approval on. Therefore, start early and be prepared. Spend time learning where your gaps are so you can proactively close them, and train your team so that their responses will result in limited or no findings. Good luck!