You’re working away on your laptop and sipping coffee; just another day at work or so it seems, when you get a call that makes your heart race and suddenly you’re as alert as a bird in springtime. The US Food and Drug Administration (FDA) investigator is waiting patiently to be greeted at the reception. This scenario cannot be avoided if your company falls under the FDA’s jurisdiction, but what follows next is completely within your control. You can head out and meet the official confidently with a smile, or offer up prayers and hope that you don’t get into too much trouble. The second alternative is something that we definitely want to avoid. Trust me when I say that being penalized by the FDA is no fun! The FDA inspection doesn’t have to be scary. If you are prepared and have been consistent in following all the rules and regulations, you have nothing to worry about! While an inspection is never fun, we have compiled a list to make it hassle-free.
But first, what is the FDA?
The Food and Drug Administration (FDA) is a US federal agency operating under the Department of Health and Human Services (HHS). The FDA is responsible for ensuring the safety of the public by supervising the manufacturing and distribution of food, pharmaceutical drugs for humans and animals, medical devices, tobacco, and other consumer products. The FDA inspects the manufacturing sites to ensure that the quality is not being compromised and that all the rules and regulations are being adhered to. Even foreign facilities are not exempted if their products are being distributed in the US.
Types of Inspections
Before getting ready for an inspection, you should be aware of the different kinds of inspections that the FDA is likely to conduct. The companies manufacturing high-risk products and those seeking approval for a new product/process are given top priority. The companies who had been previously slack in following the guidelines are also targeted.
Pre-approval: This is done when an application is submitted to the FDA for approving a new product. The FDA conducts a thorough inspection to ensure that the facility is capable of manufacturing on a commercial scale and if all the current Good Manufacturing Practices (cGMP) are employed. The quality systems will be analyzed and they have to be up to the mark. No product can be legally distributed in the US without the approval of the FDA.
Routine: This is the routine inspection that is conducted once every 2 years for domestic facilities and once every nine years for foreign facilities. Full inspections are conducted if you have never undergone one before. Since it is not practical for the FDA to conduct a full inspection for each site, abbreviated inspections are conducted for those facilities who have already undergone a full inspection before without any compliance issues.
For-cause: The FDA will conduct a probe in cases where concerns have been raised by customers or employees or in relation to a specific incident. Suspicion of fraud or non-compliance is enough to warrant the FDA knocking on your door
Compliance follow-up:If the inspector finds compliance issues at the site, a Form 483 will be issued citing all the violations. The FDA will revisit the site to follow-up and ensure that the corrective actions are in place. Post-approval inspections are to be expected after an application has been pre-approved by the FDA. This is usually conducted 8-12 months after the product hits the market.
Make the procedure clear and concise
The procedure to follow when the inspector arrives on-site should be clearly laid down and understood by everyone. Everyone should be made aware of their responsibilities and how to behave
The security personnel should know whom to contact on the arrival of the inspector/inspectors.
The inspector should be given a tour of the facility and he/she should also be accompanied by an employee at all times. He/she should be shown the basic layout- cafeteria, restrooms, etc.
Knowledgeable people who can communicate well should be chosen to interact with the inspector. This does not mean that the others are exempt from the questioning process.
Employees should be coached to only answer to what is asked of them. Providing unnecessary information is not a good practice.
Answer truthfully and if you don’t know the answer to a question, don’t guess. Tell them that you don’t know but that you will find out for them. Telling them what you think they want to hear will land you in trouble!
Most importantly, don’t panic and go about your routine as usual. Switching up the routine will cause chaos
Make the key documents and records easily accessible
Maintain a ‘war room’ to assemble and keep all the necessary documents and records on hand. Being prepared is the key. You will have some idea of what documents the FDA inspector will want to see on arrival. Make a copy of them and organize so that they can be retrieved easily. The documents may include quality reports, SOPs, manuals, etc. The inspection is a lengthy process and delays in procuring the requested documents will further lengthen it. Furthermore, the inspector may think that you’re hiding something or that there is a general lack of organization. You do not want the inspector to have such impressions about your organization!
Keep the documentation updated
Maintaining records will make your task a whole lot easier. Keep records of any recalls that you have received and the corrective measures undertaken. The inspector will definitely want to see this. He/she may also want to examine your risk management process. Keep all the documents current and updated. Make note of consumer complaints received (if any) and the actions taken in response. Remember that if your documentation is not up to the mark, you have to give valid reasons as to why it is so.
Also, make sure that you have a scribe to note down all the observations the inspector makes. It is not allowed to record audio, video or to take photographs during the inspection process so you’ll have to do with jotting down all the important points.
Conduct mock audits to stay on top
Conducting audits will help the employees to better understand the process and beprepared for when the real FDA inspector walks through the door. The audits will also help to identify the gaps and the areas that require improvement. The audits can be conducted internally but it is better to bring in an outsider. This will ensure that the investigation is unbiased and will closely resemble the real deal. It may be a little scary but the intention is for it to resemble the real thing as much as possible. The mock audits should be tougher than the one conducted by the FDA official. The employees should be coached on the Dos and Don’ts and how to interact with the inspector. There should be a clear plan as to how the inspection will proceed once the inspector walks into the building.
Don’t Panic and Stay Calm
The key to acing an FDA inspection is to stay calm and go about your business as usual. Inform the employees discreetly about the inspector’s arrival but do not make any changes to the routine. A little panic is to be expected since an FDA inspection is a little stressful no matter how prepared you are, but try to stay calm and collected. The inspector is likely to make observations during the inspection. Listen carefully and ask for clarification if you do not follow but don’t try to rectify the mistakes right then. Even if you don’t agree with them, don’t become argumentative; try to put forth your views in an objective manner with evidence. The inspector may hold a ‘closing conference’ after the inspection. This is your last chance to clarify doubts and clear any misunderstanding before the report is filed. Make the most of it to make your company more compliant!
Sure, the prospect of facing an inspection by the FDA can be pretty daunting. You may be nervous and unsure of how to go about it in the right manner. Don’t worry! You can ace it with the right attitude and preparation. Preparation is key. Instead of viewing it as a burden, think of it as a way to showcase how compliant your company is. After all, the FDA makes these rules for the safety and security of the public. This is good, not bad. If you start thinking this way, you will stop dreading it and accept it as something inevitable, but not necessarily unpleasant. If you want to share your own experiences with the FDA or have any queries, please head to the comment section below!