Piling on
"Let me set the background for you," recounted our GMP Agent-In-Place. "The year is 1980 and FDA had been at us for years
to find a better method to test the active ingredients in our product, preferably a then-modern gas-chromatography method.
We reported that, while we were working industriously at this, the methodology wasn't ready yet.
"Then, the FDA inspector showed up, as usual without warning. We didn't have a conference room available right then, so I
put the inspector in my office for a couple of minutes while I organized the space," lamented our Agent. "I had the usual
quality-assurance desk piled high with papers. I work under the stratigraphic method of filing: the older the document, the
further down the pile it is.
"The inspector spent his time in my office looking at the documents on the top of the desk, including a four-month-old report
describing a GC method for testing this multi-ingredient product and concluding that the method was qualified and worked well!"
cried our Agent. "And boy, did I hear about it then!"
A fly in the flue?
"As is routine in FDA inspections, the inspector, the manufacturing manager, and I walked through the manufacturing areas—in
this case, the cleanrooms surrounding the aseptic filling area," recalls our GMP Agent-In-Place. "And wouldn't you know it,
a fly was buzzing around the inspector's head. When he swatted at it, the fly flew away, chased by the manufacturing manager.
"The manager soon returned and, to my embarrassment, proudly stated, 'I have it trapped in the supplies storage area,
and Joe [an area employee] will remove it.'
"I waited stoically for the citation, but the inspector never wrote anything about the incident."
Inspector 54, where are you?
"The inspector who usually comes to our site works at a resident post outside of the city, but his boss works in the main
office in the city. Our inspector evidently gave his schedule to his boss," laughs our GMP Agent-In-Place. "The boss called
our site pretty often looking for his inspector. I fielded the calls, and the boss would ask if I knew where the inspector
went!
"Only later did we learn that our inspector had relatives in the area, and apparently he would sneak off to visit them on
FDA time, instead of visiting us. Of course, that was just fine with us."
Two sites, one inspector
"We have two sites near each other, and sometimes the same inspector covers both sites, although the functions performed at
each site are very different," reports our Agent. "While we wait for materials or information, we chat with each other and
the inspector, as much for our own sanity as to distract the inspector from realizing how long the request is taking to fulfill.
"So one day, the inspector, a man about 5'7" tall and of slender build, starts telling us about the inspection last week
at our other local site."
Our Agent notes in an aside: "The site director there is 6'8" tall, big-boned, big-voiced, and tends to stand over employees
and browbeat them to gain agreement."
The inspector went on to say, "And if that big $#@&%# stood up one more time and yelled, I was going to bring in the Federal
Marshals."
