The FDA had sent one of their best and toughest inspectors. The facility was located in Costa Rica.  I had been sent there from the US to help a sister company with a pending inspection.

I had arranged a dinner the night before the start of the inspection at a (supposedly) nearby restaurant in order for the FDA inspector and his wife (did I mention he brought his wife with him?) to meet the President of the Costa Rica company. With any luck, it would help the upcoming inspection go smoothly.The inspector and his wife landed in Costa Rica in a typical late afternoon thunderstorm. As planned, I met the inspector, his wife, the company president and his wife in the lobby of the hotel where I was staying. Due to not having enough room in the car, I took the liberty of hiring a taxi for the inspector and his wife. “Tres Rios, por favor” I told the taxi driver.

The President, his wife and I drove to the Tres Rios restaurant and were there within minutes. We got our table and waited for the FDA Inspector and his wife to arrive. 10, 20, 40 minutes passed and no inspector. The President was staring a hole in my head and he asked me “what did you do with the FDA?…where were they?”

I had no clue. I walked outside the restaurant, walked up and down the street thinking they were lost and looking for the restaurant. I didn’t see them. Sullenly, I went back to the restaurant and waited. The company president was pissed and started to issue my ultimatums if I “had lost the FDA!” After an hour and 15 minutes, the only thing we could think of was to go back to the hotel to see if they maybe went back there.

We got caught in traffic on the way back and did not arrive for another 45 minutes. I ran to the gentleman at the front desk and inquired if he had seen the couple. “Si!” and he pointed towards the bar next to the pool. I raced down to the bar where I found the investigator and his wife looking ruffled and 4 drinks into it. His wife saw me first.

“Do you know how many 483 observations you just got?!” she shouted across the bar.

“Oh my God! What happened?” I exclaimed. They were both pretty intoxicated in their effort to recover from their harrowing adventure. It turns out that “Tres Rios” is not only the name of a restaurant, but also the name of a town in the jungle in the middle of nowhere. The taxi driver drove them out there (as accidently directed by ‘yours truly’), stopped the cab and then told them to “get out.”

The inspector and his wife thought they were being kidnapped and refused to get out of the cab in the middle of nowhere. “Take us back to the hotel!” they yelled in English. “But we are here!” the driver emphatically said in Espanol. “Pay me and get out!” The driver didn’t speak English and they didn’t speak Spanish. No matter how hard either party stated their case, the other couldn’t understand. Not knowing what else to do, the driver got on his cell phone and called a friend and said in Spanish, “I took these crazy Americans where they wanted to go but they won’t get out of my cab! What do I do?” His friend told him “Try taking them back to the hotel.”  Finally, the driver started the taxi, turned the car around and headed back to the Cariri Hotel.

“Oh God…I am soooo sorry! I had know idea! I don’t speak much Spanish and don’t know my way around Costa Rica! I am so sorry….”

“Well you better be! If this is any sign of how the inspection is gonna go, I pity you!” They were dead serious. I bought the next few rounds and learned more about them and their fear of foreign lands. By the end of the night, we were all friends and had laughed off my huge mistake. While no one would let me forget that night, our camaraderie grew but would be further put to the test in two days. In two days it would be 9/11……..

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspector ProfilesEnforcement Analytics, and GMP Regulatory Intelligence.

Morris Sherwood has participated in about 30 FDA inspections on 3 different continents. Each inspection has not been without adventure. In his spare time, Morris is a Compliance Guru for Sherwood Int’l Consulting group and can be found at [email protected]

Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Webinar: Comparing and Analyzing Russian, UK, and US Top Ten Pharma Inspection Findings FY 2019

Presented by Jerry Chapman on October 29, 2020

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Turning Failure into Success

Presented on Tuesday, April 27, 2021 by Steve Greer, Executive Coach, Genesis Assist, and former Quality Leader, Procter and Gamble

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Quality Management Systems for Small Pharma and Biotech Firms

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An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

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Champion of Change - 3Cs to Success

Webinar: Champion of Change - 3Cs to Success

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Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Webinar: Impact of the Global Pandemic on Recent Data Integrity and Regulatory Non-compliance Trends

Presented by Paul Smith, Agilent Technologies on Aug. 26, 2020

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Past, Present, and Future of Quality Culture

Presented by Regulatory Compliance Associates Distinguished Fellow Susan Schniepp

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A.I. for Quality and Compliance Teams

August 3 webinar

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Human Factors – Compliance and Applications

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