Vermin in the ISO-8 Area

In an April 25, 2016 FDA warning letter which was prompted by communication of an adverse event (four patients ended up in the hospital after taking products made at the facility) by the Arkansas State Board of Pharmacy to the FDA.  The resulting inspection identified serious deficiencies in the production of sterile drugs.  Findings included:

  • Vermin (five insect-like pests, including a live worm-like pest), in the ISO 8 area adjacent to the clean areas
  • Tech’s cleaning the ISO5 area wearing non-sterile gloves
  • Poor practices in that the Tech’s touched a garbage bin liner and continued to clean the ISO5 area without sanitizing their gloves
  • Failure to maintain required pressure between the ISO7 and ISO 8 areas.

As reported in the warning letter, the firm has taken actions to correct these issues, however several of the corrections were deemed inadequate in that they could not be evaluated for adequacy based on a lack of information provided by the firm.