Courtesy of one of seasoned compliance and quality directors we talked to, here’s some practical advice for the actual day of the inspection:
- Ensure that the staff projects a calm confidence of their processes and procedures so they can speak to them clearly and accurately. Make sure everyone stays “on point”, particularly for discussions of shortcomings / problems. There is nothing as disconcerting for an inspector than hearing 5 different stories from 5 different people about the same problematic event.
- Train people about how to interact with inspectors. For example, understand that inspectors often use silence as a technique to elicit information. Resist all temptations to fill the void. (We heard of one company training their employees this way: If the FDA inspector asks you, “do you know what time it is?” You should answer, “Yes.”)
- Actively manage the company side of the inspection with experienced people who can remain calm and confident and ensure that the right documents and people are provided quickly to answer inspectors’ questions. Don’t ever let an inspector sit without anything to do / read / evaluate. On the other hand providing the wrong document quickly or providing one that has self-incriminating information on yellow “stickies” or written in the margins is self-defeating. Take the necessary time to effectively review the documents and make sure they are on-point to the inspectors’ request and are both internally consistent and consistent with other documents that may have been provided on the same topic.
Other 483 Resources
- The largest online 483s store (with thousands of FDA 483s in PDF format) Search by inspector or company>>. Readers of this blog receive 20% off – enter “fdazillablog” at checkout.
- The only searchable listing of 483s
- FDAzilla Inspector Rank – how often does your inspector issue 483s?
- FDA 483 article archives