FDA Audit? Take These 5 Steps Now to Protect Your Company

Experienced FDA Audit Team

Do you need legal assistance in connection with an upcoming FDA audit or inspection? If so, then do not hesitate to get in contact with an experienced FDA audit defense attorney.

The Food and Drug Administration (“FDA”) is a federal agency of the Department of Health and Human Services. To carry out its mission of protecting society from dangerous or misleading products, the FDA often conducts numerous audits of FDA-regulated products to evaluate compliance.

These audits can cause multiple problems for companies who fail to maintain compliance with FDA laws, regulations, and guidance.

Retaining legal counsel can help safeguard your business and protect yourself and your company from the legal repercussions of a negative FDA audit or inspection.

At Oberheiden, P.C., our attorneys and professionals are experienced in handling FDA audits and inspections. Our team includes former FBI agents, former U.S. attorneys, and former prosecutors as well as attorneys from the private sector.

We can assist you in dealing with varying aspects of FDA audits and inspections. Do not wait to get in touch with an FDA audit defense attorney today.

Call or contact Oberheiden, P.C. today for a free consultation to discover how to protect your business and reputation.

What is an FDA Audit?

An FDA audit is an examination of companies dealing with FDA-regulated products to determine whether that company is compliant with applicable FDA laws, regulations, and guidance. FDA audits are typically referred to as inspections.

Manufacturers, suppliers, processors, pharmacies, and various other company types are inspected by the FDA. Also inspected are medical clinics, laboratories, and foreign manufacturing and processing sites for FDA-regulated products sold in the United States.

In order to protect society from unsafe or misleading products, the FDA conducts several types of audits including:

1. pre-approval inspections sent by companies seeking to market a new product to the public;
2. routine—oftentimes unannounced—inspections of a company with FDA-regulated products; and
3. “for cause” inspections where the FDA becomes aware of issues within a certain company indicative of FDA violations.

Steps to Protect Your Company from an FDA Audit/Inspection

FDA audits or inspections can be worrisome to companies mostly because they are usually unannounced. FDA inspectors are not required to give advance notice of their arrival to the company in order to conduct an audit.

Once the inspector arrives, the inspector will mention that they have arrived to conduct an audit. However, at this point, it may already be too late if your company is not adequately prepared.

Below we offer five steps you can take now to protect your company shall a situation mandating an FDA audit arise:

1. Hire a team of attorneys experienced in handling FDA audits/investigations for their clients.

The FDA is an aggressive agency committed to investigating and auditing individuals and companies that deal with FDA-regulated products in order to protect the public from misleading or harmful products.

An inspection or audit—if unprepared—can cause multiple problems for your company. This is why it is critical to hire an attorney experienced in FDA-related audits and inspections.

An FDA attorney can help your company become prepared for an FDA audit, which is oftentimes not arranged in advance. Therefore, being prepared for unexpected audits is crucial for its successful completion.

An attorney will evaluate your company’s operations for internal and external compliance. As key parts of such compliance reviews, your attorney will be able to identify risk exposure from its assessment and develop strategies to respond to risks and weaknesses.

Having an attorney on your side is also beneficial because the attorney would be able to handle all communications and negotiations with the FDA on your behalf.

Lastly, shall a formal investigation be initiated against your company, your FDA attorney will vigorously defend you whether in settlement negotiations or in litigation in court.

2. Be familiar with FDA regulations as well as the type of audits/inspections for which the FDA may conduct.

The FDA has the authority to conduct audits of individuals and companies in connection with FDA-regulated products that are deemed misleading or harmful to public health.

The FDA inspectors who conduct the audit follow the FDA’s Compliance Program Guidance Manual (“CPGM”), which sets forth the activities for which they evaluate industry compliance with FDA laws.

In order to best be prepared for an FDA audit, companies should be knowledgeable of all relevant FDA regulations that affect their business and are specific to their location, business size, industry, and mission.

Companies should also understand that the FDA can conduct one of three types of audits depending on the objective of the FDA, the necessity for the audit, and the current operations or activities of the company.

For instance, companies that seek to market a new product need to submit an application to the FDA and must then receive a pre-approval inspection. It is relatively easy for companies to be prepared for these inspections, as companies typically have more control over when these inspections occur and the scope of the inspection’s activities.

As another example, when the FDA becomes aware of a certain problem within a regulated facility or company, it may conduct a for-cause inspection. Companies may not be given advance notice of these inspections.

Lastly, the FDA may also conduct routine inspections of companies dealing with FDA-regulated products. While these are the most common types of audits, they tend to cause many problems for companies who are unprepared.

Therefore, the best remedy is to be prepared and have an FDA defense attorney on your side to evaluate your compliance with FDA laws, communicate with the FDA, and defend your company.

3. Understand the FDA’s process of conducting a routine inspection.

If your company must complete an audit or inspection by the FDA, it is important to be aware of how the inspection process proceeds.

This allows company personnel to be prepared when the inspector arrives—which demonstrates company confidence, quality management, and compliance.

Briefly, the FDA investigator will arrive at your company and present FDA Form 482—Notice of Inspection. It is recommended that a member from company management accompany the inspector through the company’s facilities.

The inspector will evaluate many aspects of your company’s operations including the following, as some examples:

• Production process of FDA-regulated products;
• On-site operations and personnel activities;
• Company records;
• Deviation reports;
• Company quality plans and goals;
• Audits conducted of your company;
• List of product recalls;
• Quality of equipment used in production process;
• Training procedures of company personnel;
• Internal compliance evaluations, product and personnel performance reviews, or management reviews;
• Risk analysis and plans for corrective action for identified weaknesses and risks; and
• Strength of any whistleblower programs and internal complaint procedures;

After the inspection, the investigator will discuss its primary findings with company management and provide management with FDA Form 483—Inspection Observations—which would help the company develop its own solution to identified issues.

Your company may be given deadlines or other instructions on how to respond to the investigator’s notes. Any disagreement you may have at this stage should be noted.

The FDA inspector will then make an Inspection Report regarding your company’s compliance. If there are any violations of federal law noted, the FDA inspector will consider taking more formal disciplinary actions such as warning letters or enforcement action.

4. Always provide truthful information to the inspector.

The FDA inspector will not take kindly to aggressive behavior, disorganization, active concealment, and excuses. Hindering the progress of an FDA inspection could lead to obstruction charges and be devastating for the future of your company.

It is important to remember to always be truthful and prompt with the FDA inspector. The key to achieving this is to notify your company personnel of either an upcoming FDA inspection or the possibility of one in the future.

All company personnel should be aware that an FDA inspection could be conducted at any time and that they should always be following company protocol, bylaws, and compliance policies.

FDA inspectors may have to interact and communicate with various company personnel with different functions. These individuals should be aware on how to respond and accommodate FDA inspectors and how the inspection process works.

5. Ensure that documents and records that would be of consequence to a possible FDA audit/inspection are readily accessible and organized.

Audits or inspections by the FDA can happen any time and any day. The importance of being prepared as much as possible cannot be overstated.

This is especially important because some procedures can take longer than a day to complete, depending on the size and complexity of the company and its operations.

The most important step here is to ensure that all documentation and relevant information that the inspector will require is available and stored in a convenient on-site location.

These relevant documentations and information should be readily accessible and promptly delivered to the FDA inspector upon request.

Such actions demonstrate organization and thoroughness.

Put our highly experienced team on your side

Dr. Nick Oberheiden

Founder

Attorney-at-Law

John W. Sellers

Former Senior Trial Attorney
U.S. Department of Justice

Local Counsel

Joanne Fine DeLena

Former Assistant U.S. Attorney

Local Counsel

Lynette S. Byrd

Former Assistant U.S. Attorney

Partner

Amanda Marshall

Former U.S. Attorney

Local Counsel

Aaron L. Wiley

Former Federal Prosecutor

Local Counsel

Roger Bach

Former Special Agent (OIG)

Gamal Abdel-Hafiz

Former Supervisory Special Agent (FBI)

Chris Quick

Former Special Agent (FBI & IRS-CI)

Kevin M. Sheridan

Former Special Agent (FBI)

Ray Yuen

Former Supervisory Special Agent (FBI)

Dennis A. Wichern

Former Special Agent-in-Charge (DEA)

Need Advice Regarding FDA Audits/Inspections?

FDA audits or inspections are important tools used by the FDA to evaluate the internal operations of a company that deals with FDA-regulated products—whether relating to the company’s advertising, labelling, claims asserted, or other marketing or selling behavior.

It can be hard to gauge the scope of an FDA audit or when it may occur because these procedures often take place with little or no notice. Because of this, it is better to be prepared ahead of time by taking critical steps to protect your company from an FDA audit/inspection.

At Oberheiden, P.C., our team of FDA defense attorneys and professionals can help you become prepared for an upcoming FDA audit by evaluating your business operations, identifying red flags, and performing a compliance review, as some examples.

Do not wait to be caught off guard by a sudden and unannounced FDA audit. Be prepared. Be proactive. Take action to protect your company.

Let Oberheiden, P.C. advise you on how to accomplish these goals. Call or contact us today for a free consultation to protect your reputation and business and safeguard your future.