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FDA audit series part 2, what to do when the FDA arrives

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Compliance Insight, Inc.
Compliance Insight, Inc.

This document outlines steps to take when FDA inspectors arrive for an audit. It advises preparing key personnel and minimizing major activities if the visit is expected. If unannounced, call necessary people like management and QA and take the inspectors to a meeting room. Obtain their purpose and audit plan. Guide the inspectors but let them lead the process, and take notes on discussions. Provide information to areas being audited and discuss logistics like timing. Pull in resources and be courteous and professional throughout the inspection.

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Part 2 – What to do when the FDA arrives
• You asked for it… Wanted more review of the steps involved • This series is designed in parts • • • • • Part 1 – Preparing for the FDA Part 2 – What to do when the FDA arrives Part 3 – What to do while the FDA is there Part 4 – What to do during closeout Part 5 – What to do with the 483 This is Part 2 – What to do when they arrive?
If you know they are coming, you at least have some chance to prepare • Don’t let key people go on vacations • Keep major activity to a minimum, if possible • Keep a high vigilance on any potential issues If they just show up, then you have to deal with the situation. Prepare: • Do the guards or receptionists know who to call? Where to place the FDA? • Who will you call? • Where will you host the inspection? • White boards cleaned and trash removed from room?
You get the call….they are here! Take a deep breath. Relax. Call the necessary people – management, OPS, QA, QC, corporate, etc. Get a pad of paper, pen and business cards. Go get the inspectors, verify that they have signed in to enter the facility and take them to the meeting room. You will receive a 482 at this point. If the inspectors don’t tell you – ask: What is the purpose of the audit? Where will they go? How long do they anticipate the audit to last? Can you have review meetings at the end of the day – any issues? Where will they go next?
Just like a dance, you let the inspector lead the audit. You can guide or suggest certain things, but at the end – they control the process. Don’t deny them access or challenge their authority – unless… • They are looking at personnel info (pay rates, reviews, etc.) • Monetary items – pricing structure Be friendly and courteous – professional. Take notes – what is discussed, answers, who is there, etc. If they get a copy of something, you get a copy of it.
Verify that everyone is aware of the audit Pass along any information possible to the areas being targeted for the audit Discuss the timing for the days to come – start, stop times; lunch brought in or will they leave Prepare for lunch for your staff – you don’t want people leaving or skipping lunch Pull in the necessary resources
Call us at 513-860-3512 See our website at www.Compliance-Insight.com Send us an email at info@Compliance-Insight.com Thanks for watching!

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FDA audit series part 2, what to do when the FDA arrives

  • 1. Part 2 – What to do when the FDA arrives
  • 2. • You asked for it… Wanted more review of the steps involved • This series is designed in parts • • • • • Part 1 – Preparing for the FDA Part 2 – What to do when the FDA arrives Part 3 – What to do while the FDA is there Part 4 – What to do during closeout Part 5 – What to do with the 483 This is Part 2 – What to do when they arrive?
  • 3. If you know they are coming, you at least have some chance to prepare • Don’t let key people go on vacations • Keep major activity to a minimum, if possible • Keep a high vigilance on any potential issues If they just show up, then you have to deal with the situation. Prepare: • Do the guards or receptionists know who to call? Where to place the FDA? • Who will you call? • Where will you host the inspection? • White boards cleaned and trash removed from room?
  • 4. You get the call….they are here! Take a deep breath. Relax. Call the necessary people – management, OPS, QA, QC, corporate, etc. Get a pad of paper, pen and business cards. Go get the inspectors, verify that they have signed in to enter the facility and take them to the meeting room. You will receive a 482 at this point. If the inspectors don’t tell you – ask: What is the purpose of the audit? Where will they go? How long do they anticipate the audit to last? Can you have review meetings at the end of the day – any issues? Where will they go next?
  • 5. Just like a dance, you let the inspector lead the audit. You can guide or suggest certain things, but at the end – they control the process. Don’t deny them access or challenge their authority – unless… • They are looking at personnel info (pay rates, reviews, etc.) • Monetary items – pricing structure Be friendly and courteous – professional. Take notes – what is discussed, answers, who is there, etc. If they get a copy of something, you get a copy of it.
  • 6. Verify that everyone is aware of the audit Pass along any information possible to the areas being targeted for the audit Discuss the timing for the days to come – start, stop times; lunch brought in or will they leave Prepare for lunch for your staff – you don’t want people leaving or skipping lunch Pull in the necessary resources
  • 7. Call us at 513-860-3512 See our website at www.Compliance-Insight.com Send us an email at info@Compliance-Insight.com Thanks for watching!