This article was originally published on August 6, 2020. It has been updated with new information.
On May 28, 2020, Steven Niedelman, Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences practice team at King & Spalding law firm presented a webinar on FDA inspections titled, “Guess Who’s Knocking at Your Door: Assuring Inspection Success!”
Niedelman retired from the FDA in 2006 after a 34-year distinguished career, including as the Deputy Associate Commissioner for Regulatory Affairs. Niedelman’s extensive experience at FDA and as a lead consultant at King and Spalding makes him uniquely qualified to address the topic of FDA inspections.
The following was taken from Niedelman’s webinar. In his words, “This will help ensure that your folks and yourselves are well-prepared, including how to deal with FDA investigators and some of their idiosyncrasies.”
Part I below provides an overview of the FDA inspection program.
Background on FDA Inspections
Understanding FDA inspections requires understanding the role of FDA. The Agency plays a critical role in overseeing public health in the United States, in addition to engaging with various international standards-setting organizations and other inspection programs throughout the world, both on the medical device and the pharmaceutical side.
FDA’s mission is to bring safe and effective products to market as quickly as possible, but also to assure these products are manufactured, sold, and labeled correctly, are not misbranded or misleading, and that the quality systems used to manufacture them ensure consistency throughout the product lifecycle.
[Editor’s Note: For more on FDA’s mission and how it relates to inspections, view this clip from the webinar.]
FDA inspections typically assess how well firms execute their written policies correctly. Investigators review how well these policies are followed along with accompanying documentation. They also ensure that the firm can justify that procedures are adequate and adhered to.
“As those who have been inspected by FDA are aware, it is all about documentation,” he said. “The three words you should clearly remember are document, document, document,” adding “FDA regulates about twenty-five cents of every dollar a U.S. citizen spends in the United States. If you think about that, that is an enormous scope of product and responsibility with a relatively small staff.”
He also explained that FDA not just a public health agency, but also a law enforcement agency. A look at FDA’s Investigations Operations Manager or IOM shows that investigators are there to ascertain compliance with applicable laws. In fact, information gathered from an inspection may be used to support legal action depending on the violation.
“If there is evidence you are in violation of the Food, Drug & Cosmetic Act (the FD&C Act) and/or you are not following established quality system requirements, FDA’s role is to document that evidence and consider some enforcement action to be undertaken by the agency,” Niedelman said.
FDA regulates about twenty-five cents of every dollar a U.S. citizen spends in the United States.
How Can I Be Sure It’s Really FDA?
So, someone is at the door stating they are with FDA and here to inspect your facility. Yet they carry no badge. Must you let them in. The answer, according to Niedelman is “yes.”
“FDA’s authority to inspect is based upon their appearance at your firm and the presentation of credentials,” he said. “Some will have badges. Some may not if they are joining investigators in the field from headquarters. They still will have credentials, but no badges. They will issue a notice of inspection, an FDA 482. Anything that is discussed or any information that they gather prior to issuance of that notice of inspection may not be used by the agency for any type of enforcement action or any type of consideration of enforcement action. It is imperative that they issue that notice of inspection.”
Ultimately, FDA investigators can conduct inspections without an inspection warrant as the statute allows them to inspect at “reasonable times”—the times and the hours a facility is in operation. Investigators can conduct the inspection within reasonable limits and in a reasonable manner in a factory, warehouse, or any establishment where devices or drugs are manufactured, processed, packed, or held prior to interstate commerce.
From Observation to 483
“At the end of the day, your goal is not to have a list of observations issued. But if one is issued due to any observations made during the inspection, the investigators must give you an FDA 483 at the conclusion of the inspection,” Niedelman explained. “The 483 document should then be discussed with top management to ensure mutual understanding of the observations cited.”
He further explained that the term reasonable which comes up frequently by the Agency is not defined by FDA. Typically, it refers to normal business hours. Investigators may ask a site to stay open later to accommodate varying schedules, e.g., working 10 hours Monday through Thursday with Friday off. Do not feel obligated to do that.
“Some firms are willing to do it just to make the inspection shorter, and so they volunteer to do it,” he said. “But you are not obligated by any means to fulfill that investigator’s request.
“There are unusual circumstances where a certain significant public health hazard arises, and they need to get into your firm immediately. But those are not the typical inspectional requests that FDA comes out with. Those are the for-cause, emergency need types of inspections.”
At the end of the day, your goal is not to have a list of observations issued.
Current good manufacturing practices and the quality system serve as what he calls the “cornerstone of FDA inspections,” meaning these are the inspections FDA typically conducts.
“The purpose of these inspections is to ensure conformance with the quality systems—or the CGMPs—that are outlined in the Code of Federal Regulations, Title 21,” Niedelman said.
Keep in mind that an FDA inspection is a snapshot in time. He pointed out that the inspection is only based on what the investigator observes during that time at your firm, be in days or weeks.
“You are expected to be in full compliance with all the applicable portions of the quality system or CGMP regulations,” he said. “You cannot go back and say, ‘well, I passed the FDA inspection last time, so therefore I am golden.’ You are only golden for what they observed. If you receive a form 483 or if you are left with a list of observations, it will indicate that these are just the observations made during the inspection and that you have an obligation to make sure you are in full compliance with all requirements.”
In Part II, Steven Niedelman provides more details on the types of inspections FDA conducts.
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