Readying for a US FDA Inspection

Readying for a US FDA Inspection

May 23rd, 2013 // 2:35 pm @

If your company produces drugs, medical devices or nutraceuticals that fall under US cGMP regulations, your facility is eventually going to be inspected by the U.S. Food and Drug Administration (FDA).

The Federal Food, Drug and Cosmetic Act states that domestic drug establishments can be inspected at least one time every two years. The inspections can happen more frequently, such as if the drug you are producing is new, or if your facility has a history of cGMP problems.

Here is what you can expect the FDA inspector to do when he or she shows up. They can enter, observe, gather samples, interview your employees and review records that are related to the production of the drug or device product.

However, the investigator cannot have access to personnel data other than training records, any type of financial statements, pricing or sales information or research records.

What Is the FDA Investigator Looking For?
One of the best places to get a good idea about the inspection is to read the FDA’s Investigations Operations Manual, or IOM. This document is the primary guide for FDA audit policy and procedures for investigators. Generally, the investigators or looking for the following:

• Is the facility following cGMPs?
• Does the facility have proper SOPs for all operations and are they being followed?
• Is the staff fully knowledgeable and familiar with both FDA regulations and cGMPs?
• Is proper documentation available that shows proper training, monitoring and compliance?

A Word About Attitude

You can look at an FDA inspection as an intrusion and an inconvenience to normal business operations, or as a chance to show FDA what you are doing and a chance to improve your processes. Your inspection will go more smoothly if you take the latter approach!

It is only human to be resistant to an FDA inspection. After all, it does involve some amount of criticism. But that criticism can really be a good thing. FDA feedback will help you to better follow the regulations that ensure you are producing products that are of high quality, safe, profitable and will do what they are advertised to do.

SOP Tips

FDA regularly issues 483 inspectional observations regarding failure to keep accurate records and to establish and maintain SOPs. Often, the failure to create and maintain such records is due to having procedures that do not support your operational processes, or do not even exist at all.

A common mistake pertaining to SOPs is copying the FDA regulation word for word. This results in an SOP that does not give the employee any instruction for doing essential tasks. Your SOPs should consist of several sections, including purpose, scope, definitions, background, reference documents, responsibilities, revision histories and then the steps of the procedure.

Assemble a War Room

If you know an FDA inspection is coming, you absolutely need to assemble a war room. This is a strategic office that should be entirely devoted to giving all of the needed evidence that is requested by an FDA inspector during an audit.

Having a war room is going to help your company in many ways, but most importantly, it will speed your responses to FDA inspectors. One of the most important things that an FDA inspector is going to notice is how long it takes you to find requested documents. A fast response is always going to be very favorable for you. A well organized war room is what makes this possible. And if you take an hour to find a requested document….well, let’s just say FDA is going to notice the lack of organization. They also will wonder what else in your organization is not well organized.

Your FDA inspection war room should have the following:

• Desktop documentation
• Good records of data and recorded information
• Pre-selected auditees and backups

Making sure that these things are easily available is going to take some planning on your part. You should select a location for your war room that is not in the main traffic area in your office. It should be near the room where the inspector is. All electronics should be available and working – email, landline, cell phone, printer. Be aware of the nature of the documents that are going to be available for the inspection. You should make sure you have the proper sign offs for review, approval and for records. It is a good idea to do a pre-inspection dry run of your war room so you know you are 100% ready for FDA.

Any pre-selected auditees should be handled through your inspection war room before they go into the inspection arena. Proper coaching in this war room before going to the inspection interview is a good idea – it will set up the right tone for the auditee. Also, if the availability of the auditee changes, then your war room will have time to regroup and can get a back up auditee ready.

The leader in your war room should have several items available at the ready when the inspection starts:

• Your quality system manual, or the master plan for the site.
• Your organization chart that shows how the quality and regulatory departments relate
• Important SOPs that manage your compliance and quality systems. This includes CAPA, internal audits, record control, change control, master batches, and also process flow diagrams.
• Proper permissions for file access, or people who can access all critical information.

In addition to a war room, below are some of the most important tips to follow before, during and after your inspection:


• 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!).

• 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?

Random Tips

• 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.
We hope that by following the tips and guidelines outlined here, your next FDA inspection will be a much more successful and positive experience.

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