FDA Audit

Don’t Worry, This Will Only Hurt a Little

Receiving a notification of inspection from The Food and Drug Administration (FDA) is akin to an unexpected visit from your in-laws. You know it's on the horizon, but the mere thought of it sends chills down your spine and makes you question every word you say while hastily trying to tidy up every nook and cranny. It’s a roller coaster of emotions – from sheer panic to relief when it’s finally over. Although FDA audits can be daunting, costly, and time-consuming, they are a crucial aspect of ensuring that the products you bring to market are safe for consumer use and that your business adheres to regulatory standards. However, you can survive an audit with your sanity and company intact!

The More You Know…

Whether you are in the pharmaceutical or medical device industry, understanding FDA regulations applying to your specific area is essential. Reading and interpreting the regulations can be a daunting task, to say the least. Fortunately, the FDA provides"Guidance Documents" as a study guide to assist in understanding the regulations. However, if you prefer a more hands-on approach, there are companies that offer comprehensive training and guidance to ensure that you're on the right track!

It's crucial to operate your quality system as if the FDA could audit you at any given moment, once you've identified what's needed for your company. But don't be fooled into thinking that a bigger quality system is always better. It's important to only take on requirements that you can fulfill, as trying to satisfy nrealistic standards can backfire. You won't have much time to repair any quality system issues once an audit has been scheduled, so it's best to be prepared from the start. Routine inspections may give you a heads up a few days before the FDA arrives. However, if they suspect any issues, they may show up unannounced, leaving you feeling like you're taking a surprise pop quiz. It's important to stay on top of your game and ensure your quality systems are in order because the FDA has a flair for dramatic entrances.

There are three different and it’s important to know the difference:

• Pre-approval: A requirement of pharmaceutical companies that requires an inspection before product distribution.• Routine: Once you register with the FDA, you get put on an auditors list. You will likely be audited in the first 2 years of business, and then approximately every 5 years after. It’s just a cost of doing business in the medical arena.• “For cause”: An unannounced audit, triggered by consumer complaints or adverse events, is a nightmare scenario for any medical company. These audits are no joke and should be avoided at all costs.

Power Dynamics:

If you're thinking you have any leverage during an FDA audit, think again. The reality is, the FDA holds all the power, and the sooner you accept this fact, the better. When they come knocking on yourdoor, it's important to understand that the FDA has complete legal authority to do the following:• Tell you that you are doing a great job. Seriously, this happens sometimes. An FDA inspection can go well, and the inspectors leave you with just a handshake and a smile.• Issue observations (also known as “483s”) - These are issued for “potential regulatory problems”.• Issue a warning letter - This is an escalation of the 483 observation, and you are required, by law, to satisfy the FDA’s concerns.• Seizure -The inspectors have the power to seize any and all of your company's equipment and products if they believe they are not in compliance with regulations. It's a harsh reality, but one that companies must be prepared for to avoid potential setbacks and financial losses.• Injunction - The FDA has the authority to obtain a court order to legally compel a company to cease any activities that have raised concerns or objections during an inspection

• Criminal prosecution- If you don't comply with FDA regulations, they have the power to fine your company or even pursue legal action that could result in jail time. Needless to say, it's best to stay on their good side.

Have a Plan

• Who's the point-person (team lead) and how to contact them when the auditor arrives? Have this planned out in advance.• Make sure to check the auditor's credentials. Most auditors will have credentials that include a 200-A, B, or C designation.However, if you see a "D" designation, don't mistake it for "Detective." It stands for "Dangerous." It's time to call in the big guns, i.e., legal representation!

• Do you have a policy about cameras and surveillance devices during the inspection? Make sure it's clear.• Don't start the investigation until you receive a "Notice of Inspection" from the FDA.• Define the responsibilities of the management representative during the audit.• Know which documents to show the FDA and which ones to keep confidential.• Be aware of your company's policy regarding FDA device sample requests.• Determine whether to sign affidavits.

To ensure a smooth and effective audit, it's important to assemble a strong inspection team that represents your facility. In smaller companies, this may be limited to one key individual, while in largercompanies, it may involve all department leaders. It's also good practice to assign a primary contact person for the auditor, who will be responsible for escorting them to various locations within your facility. This person should possess the knowledge and experience necessary to address any issues that arise during the audit's initial stages. By having a competent and knowledgeable inspection team in place, you can help ensure a successful outcome for your FDA audit.

Best Practices:

Believe it or not, FDA auditors are people too - some are sharp, some are confrontational, some are brilliant, and some can be quite irritable. The one thing you can be sure of is that they are individuals with their own preferences, interests, and personal lives. They are also aware that you are not thrilled about their visit. As with most situations in life, showing kindness and attempting to establish common ground is usually the best approach. Because younever know what type of auditor you'll encounter, here are some tips that generally prove useful:• Never, ever argue.• Silence is golden. Do not ramble or add unrequested information.• Do not provide misinformation (jail will not be fun)• Refrain from making assumptions. If you don’t know the answer to a question it’s perfectly acceptable to respond with "I don't know, but I'll find out."• If you are the audit lead, it’s not necessary to be the expert in every area of the company. But you do need to know who the area leads are. Let those people help you answer tough questions.• Be cooperative.• If the auditor finds something wrong, own it. And if you can, try to fix it quickly.

Observation Reponses

At the end of your FDA inspection, your auditor may provide you with an FDA form 483. This form is a list of all inspectional observations they made during the audit. These observations need to be taken very seriously and your response must be submitted within 15 days.

Your response should include the following sections:

Cover Letter: it is advisable to have your cover letter written by upper management or the head of the quality department. As mentioned before, it's important to avoid being confrontational. Instead, express gratitude for the chance to improve your facility. Provide details such as the inspection date, the auditor's name, and your commitment to addressing all identified concerns.

Response: For each observation, restate the finding. Then, use a root cause analysis tool to identify the root cause of the observation. If you need more time to complete your analysis, youcan document that information in your response. Always make sure to include a target date for completion.

Corrective action: Document any corrective actions that were instituted during the inspection, or since the issuance of the observation. If you have any evidence of implemented corrective actions, make sure to include it. The FDA likes to see facts and hard data, sharing such information can boost your credibility. Also be sure to document any planned corrective actions and provide their estimated due dates.After completing these steps for each observation, submit your response to the FDA division that conducted the inspection.

Post Inspection Activities

After the dust has settled a bit, the company’s audit lead (or management representative) should write up a report of the audit. There is no regulatory requirement for the contents of this report, but it would likely include:

• Investigator’s name

• Scope of the inspection• What documents, labels or samples were taken• Description of conversations• A copy of the investigators report• Recommendations for changes to address any deficiencies identified in the audit.

At this point, the implementation of all corrective actions becomes your highest priority. Unless you have been told otherwise, you are not required to contact the FDA again.

The End

Congratulations! You survived an FDA audit. This might seem like a very anti-climactic end to a very stressful situation. And while FDA audits can be a hassle for companies, they are essential for ensuring the safety of the products that consumers rely on. Without these audits, companies could cut corners and put consumers at risk. FDA audits are a critical tool for keeping companies accountable and ensuring they are meeting regulatory requirements. In addition toensuring product safety, FDA audits can also help companies improve their manufacturing processes and quality control measures. By identifying areas where improvements can be made, companies can reduce the risk of product defects and improve customer satisfaction.