Wednesday, February 11, 2015

Warning Letter of the Week: panicked QC analysts don't look good

Apotex has already gotten some publicity for the 483 it's gotten, but this is a pretty great little tidbit:
As a result of the above observation, your firm initiated an investigation and reported that 290 [redacted] plates and 36 media tubes under testing were missing, affecting 45 product sample batches, 12 growth promotion test batches, and 37 negative control plates.  Your firm also found discrepancies between the documentation and location of samples/plates and you indicated that the majority of the missing plates were found in the decontamination area for disposal.

In your response, you refer to an investigation and indicate that “…two analysts momentarily panicked (upon (1) learning that FDA Investigators were approaching the microbiology Lab and (2) seeing used petri plates from the weekend scattered throughout the laboratory)[sic] and directed the lab technician to immediately remove the petri plates from the microbiology lab … in an utterly misguided and ill-conceived attempt to clean up the microbiology lab prior to the start of the FDA inspection.”
Your response lacks a comprehensive risk assessment of your failure to follow procedures, your inadequate documentation system and your inadequate practices related to microbiological control. Your response failed to evaluate the effect of these violations on product quality, and did not include an assessment as to whether any other batches have been compromised.

ARPL’s inability to prevent and detect poor recordkeeping practices raises serious concerns regarding the quality system in place at the time of the inspection. Appropriate controls are essential to assure that the information used for making decisions is trustworthy, accurate, and reliable.
I presume that when the inspectors visit, it's time to be cool as ice. (Please forgive the Robert Van Winkle reference.)


  1. Reminds me of this Monty Python scene with the killer FDA inspector, er, bunny rabbit.

  2. The hard boiled lesson from this encounter is: When the inspector is at the door there is nothing to do but to pull out the dart board and start shootin'. Just don't miss the board, please!

    BTW, which reincarnation of Apotex is this? Weren't they nearly shut down in the late '90s for some IP shenanigans?