Legal Advice for Before, During, and After an FDA Inspection

“I want to talk about the warrantless search, and that’s really what an FDA inspection is,” says Neil DiSpirito, kicking off his new webinar with Redica Systems earlier this month.

“They don’t have to Mirandize you,” he says. “They don’t have to have a search warrant. You’re pervasively and extensively regulated.”

It’s a little provocative, but DiSpirito’s webinar really concentrates on boundaries: what inspectors are looking for, what they’re allowed to request, what’s legally off limits, and where some evidential gray areas are. He also touches on statutes undergirding inspections and requirements—with lists of specific citations)—as well as the basics of Form 483 and other inspection documents, the levels of enforcement actions, and plenty more.

Here on the blog, we’ll give you a sample of the legal advice DiSpirito lays out, but by all means, be sure to watch the whole webinar here.

There are people they trust and people they don’t trust.

With more than twenty years of experience in private practice, DiSpirito is an FDA law partner in the corporate and global life science practice groups of Brown Rudnick. As he describes, he helps clients when complex government regulations or decisions jeopardize transactions, mergers, acquisitions, licenses, new product applications, enforcement proceedings, administrative actions, litigation, stalled applications, or civil and criminal investigations and complaints.

He’s also the editor of a book covering some of these subjects, Bringing Your Pharmaceutical Drug to Market.

What is the FDA Really Looking For?

The list in the first slide below is probably already familiar. But the bullet points in that second slide, “What are they really looking for?” all fit an evident theme.

“There are people they trust and people they don’t trust,” says DiSpirito. “They’ll never say this, but in essence, that’s the way it works in reality.”

 

 

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Before an Inspection—When an FDA Inspector is at the Door

When any self-described inspector arrives, ask for credentials and a Form 482 Notice of Inspection. “Probably about 30 years ago, 25, 30 years ago, companies would send inspectors, phony inspectors into other companies to gather information,” says DiSpirito. It’s possible for enforcement agencies to do the same, though it’s not clear they do.

And if the inspector turns out to be from the Office of Criminal Investigation, it’s best to call your firm’s lawyer right away.

That’s when a different set of rules apply, Dispirito says. “They’ll have to Mirandize you. They’ll have to go through a lot of different steps that the [administrative] investigators don’t.”

So administrative inspectors are less constrained, and anything they find can and will be used against you, he says. “If they observe something that they feel should be elevated to DOJ for a civil suit—horrendous conditions, unsanitary conditions, other things-—they can use the evidence that they found without a warrant, and they can even use it for criminal prosecution.”

Also, when inspectors ask for more information, any information you give them voluntarily is “usable,” DiSpirito says. “Even if the company didn’t consent.” But inspectors are legally entitled only to what’s mandated by statute.

What happens if you send inspectors away? They come back with an administrative warrant, probably that same day, he says, and that’s also when you should call a lawyer. There will be questions.

During an Inspection—What’s an Inspector Entitled to?

Under the FD&C Act section 704(a)(1);21 USC §374(a)(1), FDA inspectors are entitled to relevant information about whether human drugs are manufactured, transported, processed, and packed.

But an FDA inspector is not entitled to:

• Financial data
• Sales data, other than shipping amounts, in units shipped
• Pricing data, other than what’s publicly available
• Personnel records, other than professional qualification and items affecting GMP or product
• Research data, except for data required under 21 USC 374 as “approval data”
• Internal audits, supplier audits, and management reviews

“Whether the person slipped and fell on the factory floor and took an action for [compensation] or whether the person has special accommodations or any of these other things that don’t affect the job they do, none of [the inspector’s] business,” says DiSpirito.

“So don’t hand them the full personnel file,” he says. “Once you do, it’s in their possession. And you also may have a privacy problem with your employee, who may end up taking legal action against you for putting it into government hands and making public things that shouldn’t be.”

He does not advise providing information from an internal audit to an inspector voluntarily in order to provide proof of any kind during an inspection. “You can’t just show them pieces,” DiSpirito says, “Do not bring it in, because you will open the door—as we say as lawyers—to further investigation. And then they will come in.”

During an Inspection—The Thick of It

When the inspector’s in the facility, ready to ask for documents and other materials, set him, her, or them up a “war room,” DiSpirito advises—just a conference room where you can centralize activities. “The reason you do is so you can make notes as to what’s going to be a problem and what you need to go see if you have CAPAs.”

“You want to find those [CAPAs] as mitigating documents,” he says. “So when you hand it to the person, they say, ‘You have this deviation. It’s a major one.’ And you say, ‘Yes, but we have this CAPA in here that’s working.’”

Do not lie. Do not fudge. Do not fake documents.

Keep a log of everything an inspector asks for, and “every time they go to look at something, you want to be there,” says DiSpirito. “You want to see it, and you want to document it.”

Don’t sign any affidavits. “If they start reading it to you, leave the room,” he adds. “And make it clear that you do not agree to whatever was read to you in the affidavit.”

And obviously, “Do not lie. Do not fudge. Do not fake documents,” and tell your personnel the same, he says. And remember that you have the right to remain silent and the right to consult with your attorney—use them.

Put only the relevant personnel before an inspector. “I had an inspection once where the person who cleaned the room, the janitor, was in there mopping away,” DiSpirito explains. “They came in, and he mopped away and put the scale back. [The inspector] immediately wanted to create an observation that he was moving the scale and it wasn’t being calibrated.”

“Immediately, I advise them to go to their SOP to show them that the room was cleaned by the janitorial services for sanitary purposes,” he says. “But that a GMP crew came in before starting production, calibrated everything, tested all the surfaces for bacteria, et cetera, and was fully compliant.”

Similarly, don’t let inspectors walk around and talk to personnel on the line, nor speak to personnel in any language but English. “I had a client where they were creating a lot of problems by interviewing people who were temp workers and things on the loading dock,” he says, “asking them procedures about the factory that they didn’t have to know.”

DiSpirito also cautions against allowing inspectors to take photos. “They take a picture of a machine; nobody’s thinking about it,” he says. “Now the problem is, when he goes to write his 483, or a couple of weeks later when the compliance officer reviews the report, he sees something in the background—that’s a problem.”

If you decline to allow photos, inspectors may elevate the matter, “and I’ll end up talking to their counsel,” says DiSpirito. But the two court cases FDA personnel generally cite regarding photos aren’t directly applicable, he adds.

After an Inspection—Getting a 483

Redica Systems data shows that 72% of U.S. FDA inspections have resulted in a Form 483 since June 2022. It’s been even higher recently, reaching 97% of U.S. inspections resulting in a Form 483 for human drug GMP sites after the FDA resumed in early 2022, ending a Covid-related pause.

“Post-inspection, one of the most important things you’ll ever do is sit with the investigators at the end and discuss with them what’s going to be on the 483, discuss with them what’s missing, and go find it if it is missing,” says DiSpirito.

If an inspector notices something that doesn’t rise to the level of an observation, they can’t include it in a 483. “What generally happens,” DiSpirito says, “is they’ll verbally state that, and they’ll make a note, so the next investigator that comes along in two years or whatever, or after a warning letter, will have that information and will check that right away

This is the time you can use to correct anything that was wrong.

Be sure your attorney can watch the post-inspection discussion to make sure inspectors are adding only observations that meet the required standard.

“This is the time you can use to correct anything that was wrong while they were there,” says Dispirito. “If something can be corrected while they were there and you do it properly, you put in a CAPA of the whole thing, bring them the correction.”

 

 

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