Responding To An FDA Inspection

Wednesday, December 2nd, 2015

FDA inspections are not what a pharmacist expects to happen on any given day. However, these inspections can happen at just about any time. Consider if you would be prepared if an FDA inspector walked into your pharmacy tomorrow. It is important for pharmacies to understand what occurs during and after an FDA inspection. It is also important understand some of the do’s and don’ts of interacting with an FDA inspector.

During an FDA inspection

At the beginning of an FDA inspection, the inspector will usually come into the pharmacy and request to speak with the pharmacist on duty. The pharmacist should request the inspector’s business card and verify the person is from the FDA. The inspector should have no problem telling the pharmacist what prompted the inspection and how long it is expected to last.

After the inspector provides initial information, the inspection will begin. An office should be made available for the FDA representative to use during the inspection. The pharmacy should also assign someone to accompany the inspector at all times while he or she is on the premises. That person should be one of the pharmacists or a member of the pharmacy management team. The inspector should not be left alone at any time, especially in areas where medications or records are kept.

During the course of an FDA inspection, the inspector may request copies of certain documents. The document copies should be provided, with a second set of copies being set aside for the internal inspection file.

At the end of each day of the inspection, the pharmacy management team needs to meet and go over what occurred over the course of the day.

Once the FDA inspection is complete, the inspector will likely do a wrap-up meeting with the pharmacy’s management team to discuss what was found. During this meeting, the inspector may request the owner or manager to sign a form summarizing the findings. This request should be politely declined.

After an FDA inspection

If any deficiencies were found during the inspection, the pharmacy will probably receive a letter from the FDA a few weeks or months after the inspection. The letter will outline how the pharmacy failed to meet requirements and ask for a written response to the deficiencies.

Before the pharmacy writes any response to such a letter, it should consult with an attorney who is well-versed in FDA inspections. The attorney will know the relevant case law and help the pharmacy construct a response. In many cases, this kind of carefully constructed response will make the FDA cease further action.

Do’s and don’ts of interacting with an FDA inspector

Always be polite with the FDA inspector. Hostility or impatience will make the process harder for everyone. Never leave the inspector alone within the premises. Someone should always be available to see what the FDA inspector is looking at or to hear any questions asked. Instruct employees to not answer any questions without consent from the pharmacist or someone in management.

Do not sign anything the FDA inspector provides. Many standard government forms include provisions which could end up undermining the pharmacy’s response to the inspector’s allegations. Always consult with the pharmacy’s lawyers or attorneys. It is a good idea to inform legal counsel when the FDA inspector arrives and to bring all questions forward as soon as possible.

If you need help responding to an FDA inspection, contact the attorneys at Brown & Fortunato in Amarillo, Texas. Our Healthcare Team understands the intricacies of government regulations and knows the best ways to respond. Call us at (806) 345-6300 or Contact Us by email for more information about our services. You can also visit our offices at 905 S. Fillmore, Suite 400.

This information is subject to change. Please check for updates that are more recent than the published date of this article.