A precipitated inspection
"Back in the days when FDA sometimes followed up on complaints by sending out the local inspector, we received an inspection
following a complaint about a suspension product we manufactured," says our GMP Agentin-Place. "First, you must understand
that the FDA was usually hosted by two persons at our site, my boss who was a manager in quality, and an assistant director
from production. Both of them were gone, so both of us substitutes got to host our first inspection!
Paul GilliGan/Getty imaGes
"The inspector looked at the retain samples, then the release-testing record for the complaint batch. It looked good until
he noticed small writing on the back of the test sheet where the sample weights, calculations and so forth are recorded. The
note that said, 'mixed on shaker for 1 hour prior to testing.' Needless to say the inspector found that objectionable, as
it was that extensive mixing that put the precipitate back into suspension and allowed the test to pass the limits."
We now use a leafless mint
"The complainant said our over-thecounter oral liquid product didn't taste like mint any more," recalls our GMP Agent-in-Place.
"He said he was a long time customer, and he wouldn't accept our repeated claims that there had been no change to the product's
formula or method of manufacture. You see, he noticed that the little green mint leaf had been removed from the label, and
he was sure that its removal meant there was less flavor added."
Getchyour hot product here
"We imported the product by airplane," explains our GMP Agent-in-Place. "There was the case where, the pallets with our refrigerated
product were left, apparently accidently, on the tarmac over the weekend, rather than being moved immediately into the quarantine
refrigerator. Of course it was summer, and the product cooked for three days.
"The broker's insurance company insisted we test the product, and then, when it showed up as only slightly subpotent, he tried
to tell us that we could sell it for a reduced price! In the end, the product was destroyed and the insurance company made
good the cost."
Another hot item!
"The complaint for ineffective product was handled effectively," states our GMP Agent-In-Place. "The Arizona hospital pharmacist
who called in to complain was not only the pharmacist, but he was the son of the patient. He said that the product was hot
to the touch when it was received a few days before.
"It was mid-July, his story did make sense. We explained to him that during processing, the product was autoclaved for several
hours, so we didn't expect a short exposure to shipping temperatures to be a problem, So his next tactic was that the entire
lot was ineffective, and he wanted to order a different lot to use on his mother and the customer support people weren't helping
him do this. This issue got bumped to the head of quality assurance who broke the customer support log-jam and got him the
alternate lot to use. While we never heard back from the complainant, we presume that it too arrived warm, but was effective
for his mother."
Saying it all
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