If you have or are applying for marketing authorization or are conducting a clinical trial in the United States, the FDA can inspect your facility, which could result in the FDA issuing a violation notice known as a Form 483. Sites outside of the U.S. receive prior notice of FDA inspection, but sites within the U.S. require no notice and FDA inspectors may show up unannounced. It is particularly important for U.S. sites to be prepared. Lack of preparation can lead to stress when faced with an unanticipated inspection that can result in the issuance of a Form 483. We’ve put together a few helpful tips on how to be prepared prior to the FDA arriving on your doorstop and how to avoid the most common mistakes.
First impressions are important. If companies push back and are argumentative, the inspector may go into the inspection with a mindset more inclined to finding violations. Being courteous, even if caught off guard, is to your advantage as many inspectors expect to be treated poorly or with great reservations. FDA inspectors have the freedom to speak to any employee available at the company, so it is important to train employees to politely, honestly, and directly answer any questions. Companies should appoint an inspection coordinator to serve as the primary voice of the company when communicating with the inspector. Ensure the inspector is always accompanied by at least two employees when practical and ensure the inspector is always escorted whenever they leave the designated meeting room.
It is equally important to assert that if an employee doesn’t know the answer to a question raised by the inspector, the employee should indicate this and not guess at the answer. Instead, the employee should politely request that they be given the opportunity to consult with other team members to get the information requested. The inspection can continue while the information is gathered for later presentation or the inspector may choose to wait before proceeding.
Though FDA inspectors can request nearly any data from employees (with exceptions including financial information, personal information, internal audit and management review content), employees should always focus on answering just the specific question asked by the inspector without volunteering extra information. If the question is not clear, ask the inspector for clarification before answering. Avoid appearing evasive as inspectors are trained to observe this behavior and may be inclined to dig deeper as a result. Lastly, no employees are required to sign any documents, such as affidavits, provided by the FDA inspector at the time of the inspection.
The best advice is to always be prepared. The company should use its internal audit system to identify problem areas and then follow through with CAPA activities to rectify problems and prevent recurrence. AlvaMed has a team of experienced auditors who can help you make the most of your internal audit program. Contact us to learn how we can help you.