Many compounding pharmacies have been asking “what is the difference between an FDA Form 483 and an FDA Warning Letter?”. The FDA (U.S. Food and Drug Administration) has been extremely busy and is dramatically stepping up their efforts at inspecting 503A compounding pharmacies across the nation. Officially named by the FDA as a Notice of Inspectional Observations, it is usually referenced as simply a 483 Form by most people. The 483 Form is the result of an FDA onsite facility inspection where the FDA inspector has observed any existing irregularities, potential problems and/or any deficiencies in your processes and systems that could result in unsafe conditions present that potentially could violate the FDCA (Food, Drug, and Cosmetic Act).
What Is an FDA Warning Letter?
After an onsite inspection, the FDA inspector will submit a final 483 Form to both your business and to their supervisors. It is then the compounding pharmacy’s option to submit a response within fifteen (15) working days documenting any corrective actions taken, plus all future actions that they plan on initiating to achieve compliance. However, it’s important to note that if your response to the 483 Form is determined to be lacking or insufficient, an FDA Warning Letter may be issued to your firm. Additionally, if the onsite inspection turns up with deficiencies that are serious enough in nature to warrant it, the FDA will not wait for your response, but may instead choose to almost immediately issue you an FDA Warning Letter.
This FDA Warning Letter is considered to be the FDA’s notice that you have been found to be significantly violating FDA rules and regulations. It usually lays out the FDA’s most serious concerns, but always states that the list is not all-inclusive and almost always encourages the cited firm to retain a “third party consultant with relevant sterile drug processing expertise”. The FDA attempts to make it extremely clear what is expected of your facility by the FDA to correct the existing and potential problems. It also stipulates a time period that requires you to inform the FDA of your specific corrective actions and plans for correcting the issues asap, plus it must also include any future plans that are to be established to prevent the issue from reoccurring. The FDA will thoroughly go over each response individually to make sure that both the immediate actions taken and any future actions planned at your facility are adequate to satisfy them and that the proposed corrections are deemed as sufficiently acceptable.
How Best To Respond to an FDA 483 Form or Warning Letter
Your response to a 483 Form or Warning Letter is critically important! It is best to respond as promptly as possible, thus establishing the fact that you are taking the form &/or warning as seriously as the FDA does. However, you don’t want to be reactive and state something in your response that can be misconstrued – so it’s best to take your time and get your response as perfect and concise as is possible.
You must clearly identify a “course of action” that lists each specific procedural adjustment that you are instituting immediately, plus all future actions that you intend to pursue to correct the inspector’s findings. This must be completed within the FDA’s specified time frame (which many times differs from case to case). A comprehensive response to each documented observation &/or violation that was noted is also mandatory. These factors mean that BOTH the quality and the promptness of your response to the 483 Form or Warning Letter are both critically important.
What Should YOU Do After Receiving an FDA 483 Form or Warning Letter?
Your response to an FDA 483 Form or Warning Letter is critically important. You will have fifteen (15) working days to submit your response and it should lay out your detailed plan to remedy each observation, including an expected timeline. Never set yourself an unrealistic timeline, because the FDA will hold you to it.
Consult an expert! Although these inspections are going to continue (and probably increase in frequency), the truth is that your response is the first step in “pleasing” the FDA and it needs to be both complete and accurate. Responding to such FDA forms and letters is not a skill that most business owners or pharmacists have any expertise in, yet the response is far too important to be neglected or taken lightly. Another way to look at your response is that it needs to be customized to your individual operation’s environment, policies and procedures, so a response using a generic template is discouraged and obviously not recommended. If you do not already have an active ongoing relationship with an established and experienced Pharmacy Consulting Firm, NOW is the time to find the right one. For some tips and advice on helping you choose the best pharmacy consulting company for your specific needs, please visit our previous blog post: How To Choose a Pharmacy Consulting Firm.
About HealthCare Consultants
HCC is known as a national leader in pharmacy consulting. Since 1989, our network of seasoned advisers and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with businesses of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations.
One of the services that HCC specializes in is the development and customization of both 503A and 503B Policies and Procedures. We have nationally renowned in-house experts and consultants with proven “track records” and successful results in responding to both FDA 483 Forms and Warning Letters.
We urge you to contact us today to see how our Pharmacy Consulting services can fit your needs and help you improve your business now, plus be ready for the future. With a full-time staff of experienced in-house Pharmacy Consulting specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online now or call us today at 800-642-1652 for a free consultation