It’s practically impossible to frighten longtime MedTech and pharma industries expert Jaime Santana on Halloween because over the course of his career he’s seen it all when it comes to US Food and Drug Administration (FDA) inspections, including the good, the bad, and the downright ugly.
“I’ve gone through so many inspectional situations with FDA investigators and other auditors to the point where I developed an inspection readiness program to explain to RA/QA professionals on how to deal with odd things that may happen,” said Santana, a QualityHub Principal Consultant.
“Nowadays, when I train people on FDA inspections, people will say, ‘Oh, that scenario would never happen.’ And I always say, ‘Yes, it could happen because I’ve lived through it, and that’s why you need to be ready,’” he said. “It’s not that I read a particular situation in a book; rather, I’ve lived through it.”
Below are three tales of inspections gone strange that Santana shared during a recent interview with QualityHub.
The Curious Case of the Drawer-Opening Investigator
While working at a medical device company that was being inspected by the FDA, Santana was tasked with escorting an FDA investigator to the restroom.
“We passed the administrative offices, including our finance department. The investigator then deviated from our path to the restroom, stopped at one of the cubicles in finance, and began opening desk drawers to see what was in them,” Santana said.
“I know that, yes, the FDA can open drawers, but not in the finance department. Financial documents are not discoverable for the agency and they are not something that can be audited,” he said. “I told the investigator, ‘This is our finance department,’ but he soldiered on and kept opening drawers.”
Not only did the investigator open all the desk drawers in the first cubicle, but he also opened desk drawers in two other cubicles.
“I absolutely understand why an FDA investigator wants to be thorough and open a drawer – but drawers in the finance department are off limits.” – Jaime Santana
“Finally, we made it to the restroom and the investigator went inside. In the interim, I found our quality director and told her about how the investigator was opening drawers. So, we made our way back and encountered the investigator outside the restroom,” Santana said. “The investigator immediately said, ‘I noticed that one of the employee cubicles had Wite-Out [correction fluid] in a drawer.’ I pointed out, again, that it was the finance department and that the documents they’re touching there are not quality system documents. They’re not performing quality-impacting activities.”
Nevertheless, the investigator told Santana there should be no bottles of Wite-Out in the facility – period. The investigator then said the Wite-Out discovery would be discussed during the inspection’s close-out meeting, but the subject was never brought up again.
“I’ve seen drawers opened before but it was typically in labs,” Santana said. “For example, if an investigator is touring a lab and they see a drawer or cabinet where there are scrap containers or shredding bins, they’ll open them to make sure paperwork or data is not being discarded. They want to make sure you’re not hiding things.”
He pointed out that the FDA knows there are unscrupulous manufacturers that hide data and documents, and understands that investigators need to be as thorough as possible.
“As a supplier auditor, I’ve gone to facilities where they’ve built walls to hide products and hide documents. They’ve burnt documents in the back of the facility so the FDA won’t have access to them. And I’ve conducted audits where I heard an alarm ring for a solid five minutes and there was no operator in the room to address the alarm, and yet a document that was brought to me the next day clearly indicated there were no alarms and no issues – nothing was noted,” Santana said.
“So, I absolutely understand why an FDA investigator wants to be thorough and open a drawer – but drawers in the finance department are off limits.”
The ‘Soap Opera’ From Hades
At a different medical device company, Santana was involved in an FDA inspection when the manufacturer’s quality director refused to give an agency investigator a document.
“The situation became like a soap opera, with the investigator repeatedly saying, ‘Are you going to give me this document?’ and the quality director repeatedly saying, ‘No, because that document is part of our internal audit program,’” Santana said.
“The investigator then explained, ‘It’s a CAPA [corrective and preventive action] document from your internal audit program. We have the right to see it,’ but the quality director still refused her the document,” he said. “The investigator said ‘OK’ and left the building.”
The next day, “the investigator came and asked again, ‘Are you going to give me the document?’ and again, she was denied, so she left,” Santana said. “That happened again on the third day. But on the fourth day, the investigator came back to our facility with an armed US marshal and asked one more time, ‘Are you going to give me the document?’ And not only did the investigator come with a marshal, but she came dressed in full uniform with her badge and her hat on. She was ready for battle.”
When that happened, the quality director gathered with Santana and others from the company in a conference room where they promptly contacted the firm’s attorneys.
“Legal basically said, ‘Give the investigator the document,’” Santana said. “That soap opera dragged on for four or five days and in the end the investigator ended up getting what she wanted anyway. And what’s funny is, once she got the document and read it, she had no issues and no concerns.”
After the inspection concluded, the company asked the quality director to resign for not complying with the investigator’s request.
“The whole saga was a power play,” Santana said. “The quality director did not want to be told what to do, and the investigator was indignant, with an ‘I’m the FDA and you have to do what I tell you to do’ type of attitude. As it turns out, if the investigator and the quality director would’ve just sat down and talked through why he’s saying he cannot provide the document and why she wants to see it, I think we would have arrived at the same conclusion without the drama.”
The company was given an FDA-483 by the investigator when the inspection closed, but the tug-of-war over the document was surprisingly absent from the inspectional observation form.
Santana further believes the male quality director was sexist in his approach to the female FDA investigator. “The director gave off an attitude of ‘I’m the man, I’m the top dog,’ and I’m sure the investigator felt that. I think he was pushing her buttons,” he said.
“In any event, the same investigator came back for a subsequent inspection, which was about two years later. At that point we had a new quality director and the two of them hit it off. There were no issues whatsoever. It was a great inspection.”
The VP who was AirTagged
During another FDA inspection, this time at a pharmaceutical company, Santana’s coworker placed an Apple AirTag location tracker in the bag of an executive VP of quality who couldn’t be trusted to stay away from the investigator after hours.
“The EVP was staying at the same hotel as the investigator. The EVP told us early in the inspection that he saw the investigator having a drink in the hotel bar,” Santana said. “We begged him not to talk to the investigator if he saw them again at the hotel.”
He went on: “A colleague of mine said, ‘Jaime, you know he’s going to talk to the investigator, right?’ And that’s when I said, ‘Yes, but what can we do about it?’ That’s when my colleague said, ‘I have an idea. I have an AirTag. I’m going to put it in his backpack so we can track wherever he goes.’”
But even keeping tabs on the EVP didn’t stop him from eventually approaching the investigator the next evening at the hotel bar. Despite introducing himself as the company’s EVP, the investigator rightfully said nothing in return and refused to converse.
The next day, the EVP told Santana what had happened.
“I knew we had to tackle this head on, so when the investigator came in for the day, we had our EVP introduce himself again, but this time in the proper setting, which was at the company itself,” Santana said. “Our EVP then came into the room and said, ‘I want to apologize for last night. This is the correct forum for me to introduce myself,’ and the investigator said, ‘No problem.’”
Despite noting in the inspection minutes that the EVP had introduced himself, the investigator omitted the hotel bar incident.
“It’s ridiculous that we had to go to such lengths to control the actions of the EVP of quality, and thankfully nothing bad came of it,” Santana said. “But that should be a lesson for anyone at a regulated company – don’t interfere with the FDA investigator, especially after hours when the inspection isn’t happening. Remember, there’s a time and place for everything.”