Are You Prepared if FDA Knocks at your Door?
08-17-2012
On average, investigators from the U.S. Food and Drug Administration (FDA) knock on the doors of domestic pharmaceutical facilities every two years. But a large number of complaints about a particular product could cause such occurrences to be more frequent and even unexpected.
Would you know what to expect, or how to respond if you heard that knock at the door?
I recently wrote an article for Pharmaceutical Processing, the second in a series about warning letters, addressing the FDA inspection process and highlighting some best practices to keep in mind when preparing for such an event.
As you may already know, the purpose of FDA inspections is to determine whether a company is violating the law in its manufacturing, laboratory, production or storage processes. The audit will likely consist of an examination of administrative practices and controls, as well as a collection of samples, labels and promotional materials.
In an effort to streamline the process, the agency suggests that businesses identify an Inspection Coordinator to accompany the investigator through the process. By identifying this person ahead of time, the company will be prepared to effectively manage the entire audit from start to finish. After the inspection is complete, the company will generally receive an FDA-483 Form which provides detail on any significant observations found during the on-site visit.
Carefully review this document. If you have questions, ask.
Don’t be afraid to voice concerns about any of the investigator’s findings. If there is a disagreement over an action taken by an investigator, contact FDA’s Office of the Ombudsman as soon as possible to seek a resolution. Such actions could help resolve issues and prevent negative publicity before warning letters are made public.
While understanding the findings and suggestions at the end of an inspection is significant to preventing a warning letter from being issued, so is effectively preparing a Standard Operationing Procedure (SOP) ahead of time. This document, which outlines how the company will manage the on-site visit, will define roles and responsibilities for company personnel and include prepared answers to questions that are frequently asked during the inspection process.
It is also imperative that businesses put this plan to practice. Certain corporate staff should be trained on the FDA inspection process and put the company’s SOP to the test. This will not only allow for the identification of weaknesses, but also help the company avoid receiving a public warning letter or worse, having that warning letter lead to a recall event.
Do you feel that your firm is adequately prepared for FDA inspections, both planned and unexpected? Your comments are most welcome below.
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