"According to the batch record, the operators had added the correct amount of B12. There was even a second weight check in
the manufacturing area, and it reported in-specification results.
"But when we finally got to the dispensing records, they told another story—somebody had put ten times more cyanocobalamin
into the recipe than they were supposed to. Sure, a ten-fold error sounds like a lot, but B12 is added in such small quantities
that nobody could catch it visually."
Pharmaceutical Technology's monthly "Agent-in-Place" column
distills true-life cautionary tales from the secret files of Control, a senior compliance officer. If you have a story of
operators, oblivious management, inopportune lapses of judgment, or Murphy's Law in action, please send it to Control at
We won't use any names, but if we do use your tale of disaster,
courage, or just plain weirdness, Control will send you a coveted Pharmaceutical Technology t-shirt.