What You Didn’t Know About FDA: Guide to Preparing Yourself for an FDA Audit

What Does an FDA Agent Do?

The FDA agents working with the pharmaceutical companies have to go through a variety of training courses in multiple schools. They go to drug school, medical devices school, canning school, etc., to gain exposure. Then they get many opportunities to work in different capacities for the agency. For example, they work as Consumer Safety Officer, aka Investigator, who are key players in an FDA visit to your manufacturing unit.

A Resident-in-charge has additional responsibilities of office work other than his duties as an investigator. They also have tangential relations with the Justice Department because of the criminal work practices the investigators come across with. These agents go abroad to provide their skillset to other organizations.

Difference Between an FDA Investigator and a Regular Quality Auditor:

The FDA as a regulatory authority is different from other organizations of the ilk in that it is not as health-oriented as those organizations in other countries are. It also concerns a lot of criminal work, e.g., documentation of falsification of data given to the government under a conspiracy. Therefore, it hires people that have a background in that field, too, e.g. it hires people from customs, secret service, etc. Plus, quite some agents from the FDA wear badges too.

Another difference is that a regular auditor will collect information and pass it along to his supervisor. Still, the data collected by an FDA agent will go through a long chain of scrutiny and might end up in court.

Four Concepts in the Duty of an FDA Investigator:

● Jurisdiction: FDA has authority over the interstate commerce of pharmaceutical products. The very encompassing nature of this commerce necessitates federal agency involvement.

● The Violation: The FDA agent has to determine if the code violation has been committed or not.

● Documentation: The agent also needs to document the violation.

● Responsibility: An FDA agent has a responsibility to find who was behind the breaking of the law.

Evidence Development by an FDA Investigator:

1. The Value of Evidence in FDA:

Evidence is the key to FDA’s existence. Evidence-based on risk, a risk that surrounds the product. Risk and product combine to make the whole world of FDA.

2. Evidence Collection:

The collected information must meet the criteria ‘evidence’ if the agent wants to present it to the court. The collection of data is a systematic process that becomes a property of the FDA for future references. Commonly, agents keep a diary to log down the data they collect in a specific investigation. It is not the property of the agent but the FDA. So, the agent has to be meticulous in his work. Otherwise, the mistake would become a part of the record with potentially dangerous consequences.

Mostly, the preponderance of the evidence is so great that FDA and the defender do not go to court and make a settlement outside. But rarely, the case does go to court, and it is a challenging process for both parties.

3. Types of Evidence:

The evidence from an investigation has first and foremost a testimonial nature, i.e. the investigator presents it in the court as “I saw…,” or “I observed….”. For example, “I saw the supervisor ordering the employees to destroy the sample.” This is the purest and most powerful form of evidence collected by an FDA investigator.

The second type of evidence is documentation—the agent systematically catalogue pictures, samples, and data in the documents.

4. How Is the Agents’ Testimony Verified in Court?

Firstly, the catalogued evidence backs up the agent’s testimony. Secondly, there can be an eyewitness who is subpoenaed and asked to verify the agent’s observations. Simple hearsay does not have any value in court. You have to provide material evidence in its support.

The SOPs of Sampling:

The agents collect a specimen, called a sample, catalogue it and hand it over to a custodian, who locks it away in an FDA lab. There is a chain of custody in the handling of each sample. The sample custodian is the one who takes care of all the administrative work involved in this process.

Agents can take samples for many reasons. It is not limited to a mere analysis of the presence or absence of a particular chemical in the product. Sometimes, they do it for a legal reason, e.g. to establish the jurisdiction of the FDA.

1. FDA 483 Notification:

An FDA 483 observation, or “inspectional observation,” is a notice sent by the FDA to highlight any potential regulatory violations found during a routine inspection. This can relate to the company’s facility, equipment, processes, controls, products, employee practices, or records.

It’s so powerful that the issuance of 483 can affect a company’s stock prices in the market. A 483 is not technically a breaking of law or regulations. This is simply the first step in the collection of evidence.

1. Further Proceedings:

The supervisors then send the observations to the Compliance Department, who suppose to link the observations to violations of regulations. 

People have a misconception that 483 shows a violation of regulation, but it doesn’t. Sometimes, the agent cannot articulate his observation enough to call it a violation or when they cannot back it up with evidence. On those occasions, a 483 does not stand.

Procedures for Foreign-Based Manufacturing Units:

FDA can inspect your manufacturing plant even if it is located outside the USA. And in this respect, the laws give a little bit more advantage to the FDA. Let’s talk about how this works.

1. Deterrence on Companies:

The products the USA imports from foreign countries, corn, medical devices, or sterile drugs, have to undergo a particular importation process. And FDA has the power to approve or disapprove of a product coming into the country. Suppose that the FDA wants to inspect a plant in Germany, they’ll need a permission letter from that plant owner. Then, they will get an invitation to that country to visit as a diplomat. If that plant owner does not invite FDA, then their product can be prohibited in the US.

1. Harsher Criteria:

There’s a big catch in these foreign inspections too. The investigators only have a burden to establish an ‘appearance’ of a violation. They do not have to prove it beyond a reasonable doubt. It’s only based on the investigator’s opinion, albeit a professional opinion.

1. Comparison to the US:

On the other hand, they would have to find more concrete evidence to issue a notice in the US. The criterion here for the foreign companies is more strict.

How Can a Freelance Consultant like Chavarría Help Here?

A consultant will defend the company through a series of manoeuvres that do not include lying or falsifying the evidence.

A consultant can offer advice at two levels of defending. Firstly, one can challenge the evidence itself. Secondly, if the evidence is too strong, one can question how its development. Both of these approaches minimize the impact of observations.

If there’s something the investigators have pointed out during the inspection, correct it as soon as possible. Even if it’s minor and there’s a reason behind that. An agent in making EIR (Establishment Inspection Report) and writes down every observation in detail. If you can correct the shortcoming before the inspection ends, likely, the agent will not penalize it.

Note here that the number of observations does not matter as much as the impact of each one does. Sometimes, a 483 is issued based on a single observation, e.g. design validation or a couple of them. Often, a CEO will decide not to call a private quality auditor just to cut some expenses. But this could cost him big because that private auditor might have detected one or two severe FDA observations. Especially in the case of a company located overseas.

Final Advice:

People always say, “be prepared.” But that advice does not help. The key is ‘how’ to prepare yourself. And that happens with training. You train your employees until they become the backbone of your company. They are the ones who are going to save you or ruin you in front of the FDA. It is them you have to spend your investment. Along with teaching hard skills, it is also important to inculcate the philosophy of quality in them.

Instead of only investing in heritage skills, how to do something, it’s also essential to invest in the philosophy of quality.

If You Want To Contact Luis Charles Chavarría, Visit His Official Website.

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