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Food and Drug Administration and Compliance Issues
Wednesday, March 27, 2013
More FDA Inspection Tips (And One Unforgettable Quote from the FDA Compliance Director) March 26th, 2013 // 10:06 pm @ jmpickett March 26, 2013
After our recent very informative Webinar on FDA inspection tips, we asked some of our readers what the most important things are to avoid FDA 483s. Here are some of our favorite responses:
It is important to practice inspection readiness on a daily basis. Run a mock audit often and review the findings. This way, you will have uncovered any potential FDA compliance problems. And, your quality team will be calm and confident on the day of the real FDA inspection.
Try to get your hands on FDA 483s and warning letters that are readily available from the FDA. This will give you a good idea what they are stressing in current inspections.
During the Inspection
On the day of the audit, you will want to only answer questions that FDA asks. There is one drug company out there that trained their employees like this: If the FDAer asks you if you know what time it is, you just say ‘yes.’ The moral is to keep every answer as simple as possible, and only directly answer the question asked and no more.
Have your senior management be the point people during the inspection. You don’t need to have a whole crew of people tailing the FDAers all day. Make sure you select people who are calm and confident. If you have some grumpy quality people, send them on a fishing vacation during the inspection (seriously, our recent Webinar speaker recommended just that to one client!).
Assemble a back room, or war room, during the inspection. In an ideal world, you will be able to have the conversation between the FDAers and your team piped into this room. You should have experts available from all of your product lines and QA/regulatory assurance should be ready to give any asked for documentation right away. Make sure someone knows where every document is that the FDAer may ask for. Nothing looks worse than not being able to find important documents.
Use the all-important close out meeting with the FDAer to clarify any items that are not clear. This will help you to understand what the investigator is thinking. Sometimes you may be able to clear up any misunderstandings an avoid some FDA 483 observations. You should not use this close out meeting to argue with the inspector. If there were any corrective actions taken during the audit, ask the investigator if these actions were enough.
Remember that the exit interview is critical many times to establish that senior management will do corrective actions. This can help to minimize further FDA actions. The FDAer on the inspection has much input on the compliance division decision on how to classify the audit. If senior management seems like they don’t care, you can expect the district will try to upgrade your 483 to a warning letter.
After the Inspection
After the audit, a good way to avoid a 483 is to respond to the observations as fast and completely as you can. Demonstrate that you have your stuff together. FDA is not very understanding if you have repeat violations from an earlier 483. Key – remember you MUST respond to 483 observations in 15 days, or FDA will not even open your response. You can easily flush $100,000 in consultant fees down the toilet if you do not respond within the 15 day time frame.
Just because the auditor wrote the observation does not mean that you cannot dispute it. You may dispute the facts upon which the observation is based, or you can argue whether the observation rises to the level of a 483 observation.
This has been heard directly from the mouth of the Director of the Office of Compliance: We know within 30 seconds of scanning your 483 response if you ‘get it’ or not.” Did we mention that answering a 483 quickly and thoroughly is really important?
We find that quality is mostly dependent upon the culture of your company. If people from all of the departments have a shared feeling of ownership of quality, the quality of the company will be much better. If people think that only the quality department should worry about quality, you could have trouble brewing.