Knock-Knock. Who’s There? It’s the FDA - Are You Prepared?

Mon, 08/13/2012 - 4:32am
Mike Rozembajgier

You hear a knock at the door.

When you open it, you are served with a Notice of Inspection by a U.S. Food and Drug Administration (FDA) inspector.  Do you know what to expect, or how to respond?

Businesses that do not have an adequate understanding of the FDA inspection process and are ill-prepared to manage an audit could be at a significant disadvantage.  Inspections, announced ahead of time or not, are a critical element of how FDA ensures the firms it regulates are compliant with federal law.
On average, FDA inspectors arrive at the doorsteps of domestic pharmaceutical facilities every two years. However, should the agency receive a large number of complaints about a particular product or have suspicions that there is an unreported problem, investigators may take swift action. And the ongoing scrutiny of FDA’s ability to effectively monitor the quality controls and manufacturing process of pharmaceutical therapies could lead to an increase in the number of audits in the future.
This second article in our series on warning letters will dissect the FDA inspection process and provide some best practices to keep in mind when preparing for such instances. After all, it is the well-prepared firms that have the highest probability of ensuring the success of an FDA inspection and preventing subsequent enforcement actions.

The purpose of FDA inspections is to determine whether violations of the law are occurring and, if so, to obtain voluntary corrections by the inspected firm. To that end, the audit is likely to focus on a company’s manufacturing, laboratory, production and storage processes. Investigators may examine administrative practices and controls as well as collect samples, labels and promotional materials.
In order to streamline the process, FDA recommends that companies identify a knowledgeable person at the company, such as the plant or production manager, to accompany the investigator at all times. This will also allow the company to effectively manage the audit from start to finish. The inspector will then generally ask for a tour of the facility. Upon completion of the tour, it is common practice to take the inspector to a designated meeting room to review logistics, such as the company’s business hours and when manufacturing or other operations of interest typically occur. Should the investigator not volunteer his or her plans for the rest of the inspection during this time, don’t be afraid to speak up and ask. Engaging in conversations like these will help to ensure that the audit goes as smoothly as possible and there are likely to be fewer surprises once you receive the agency’s inspection report.

The audit will generally conclude with a meeting wherein the investigator will provide the company with an FDA-483 Form, detailing any significant observations found during the on-site visit. This is the most crucial part of the entire inspection process. It is in your best interest to make sure that everyone understands any identified observations and the corrective actions that need be taken. If you have questions about anything, ask. Should you disagree with any of the inspector’s observations, speak up and voice your concern. If there is a disagreement over an action taken by the inspector, contact FDA’s Office of the Ombudsman as soon as possible to seek a resolution.

These actions could help prevent negative publicity by resolving issues before warning letters are made public.

While compliance is necessary for a good outcome to occur, having procedures in place prior to an inspection can make all the difference. In order to curb anxiety, it is pivotal that each firm develops a Standard Operation Procedure (SOP) that outlines how the company should manage the on-site visit. This plan should identify an Inspection Coordinator, who will be in charge of accompanying the inspector throughout his visit, and define the roles and responsibilities for other company personnel. It may also be worthwhile to include details about the inspection as well as answers to those common questions that will most likely be asked throughout the process.

No matter how detailed your plan may be, it takes practice to make everything perfect. Make certain corporate staff is trained on the FDA inspection process while emphasizing how to effectively answer questions during any investigator interviews. It is also wise to put SOPs to the test by conducting mock inspections to better assess employee readiness. Firms can learn where their weaknesses lie during an on-site inspection and ensure that all employees are on the same page.

Without question, inspections can be a tedious and stressful process. The more prepared a company can be, the less nerve-racking they will be in the long run. Inspections can have a profound impact on a business’ success and lead to consequences including publicly available warning letters. The next article of the series will delve into the top reasons pharmaceutical manufacturers are served a warning letter and how such information can further prepare you for when FDA is knocking on your door.


About the author: Mike Rozembajgier is Vice President of Recalls for Stericycle ExpertRECALL™. Rozembajgier is responsible for all aspects of recall service offerings, including development of strategic recall business initiatives and, product enhancements. He has more than 10 years of experience in the healthcare industry. Prior to joining ExpertRECALL, Rozembajgier held various management positions at Guidant Corp. (now Boston Scientific) and at Deloitte in the Strategic Consulting practice.





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