FDA Enforcement Guidance

FDA Enforcement Guidance

If you have received a 483, warning letter, import detention order or need immediate assistance during an FDA inspection, please call 202.765.4491 or e-mail msanchez@fdaatty.com

What We Offer

Our firm can assist you in preparing an effective response to any FDA or USDA enforcement action. Common enforcement actions from the FDA 483 and/or warning letter, managing a recall, responding to an import detention, or petitioning for removal from an import alert. We can intervene directly with FDA field agents, compliance officers, and recall coordinators to provide you the best enforcement outcome possible. We also provide you with direction and hands-on assistance in developing and implementing a remediation plan to ensure your GMP quality system will be in compliance with the FDA regulations.

We also represent doctors in FDA criminal investigations into counterfeit drugs and retailers in SNAP (food stamp) violations.

We can:

  • Analyze the findings of the FDA 483 and/or warning letter.
  • Develop a plan of action to remedy any deficiencies.
  • Develop a timeline for implementation.
  • Lead and/or assist in implementation of the plan.
  • Act as an interim management representative.
  • Be a resource to answer questions from you or the FDA during your efforts to correct the noted deficiencies.

 

Please contact us for a free consultation.

What is a FDA 483 Warning Letter?

An inspection can be an unwelcome surprise. The U.S. Food and Drug Administration (FDA) uses what is known as FDA Form 483, referred to as “Notice of Inspectional Observations,” to cite major violations discovered during an inspection.  The 483 notice is issued by an FDA field investigator after an on-site inspection; it lists deficiencies in your quality system, but can also include other violations like labeling, failing to file an adverse event report like an MDR or failing to properly issue a recall. The observations contained in every Form 483 are based on the inspector’s evaluation of your operation and on his or her interpretation of the regulations and how they relate to your operational good manufacturing practice (GMP) quality system.

The field inspector will submit the finalized 483 notice to his/her superiors, and based on the severity of the findings, an FDA warning letter may be issued to your firm.

What do I need to do if I receive a FDA 483 or Warning Letter?

You must respond to the FDA 483 warning letter in a timely manner and identify your plan to implement a corrective action program to remedy the findings. A detailed response to each finding will also be necessary for each item addressed. The quality and promptness of our response to this letter is extremely important. Often, the FDA will require a company who receives a 483 warning letter to hire a consultant to assist in the resolution of the findings. Even if the FDA has not made this mandatory as a result of your particular warning letter, the FDA looks at this voluntary action as a commitment by your company to bring it back into compliance.

The FDA Detained my Shipment from Entering the US, Now What?

There are a number of reasons a shipment can be detained at the point of entry. Unapproved medical devices, misbranding (improper labeling), and potential adulteration are among the most common violations. We can help you quickly identify the reason for detention and work diligently to resolve the issue. A quick and effective response will help you avoid a warning letter, publication on the import alert list, or other penalties.

Recalls

If you’ve received a product complaint or report of an injury or illness, then you need a rapid response. Our firm can help you manage all aspects of a recall or adverse event/illness report.

Import Alerts: If the FDA customs detained your product an immediate response is required to avoid listing on an Import Alerts. Import Alerts are publicly published notices of violations that also allow the FDA to detain every shipment that enters the country. If you’ve already received an Import Alert, such as Import Alert  89-08, we can help petition the Agency for removal. Our firm offers experience working with clients from South Korea to Canada and Europe to petition the FDA for removal from an Import Alert.