Abbott warning letter
Executive Summary
Company's North Chicago, Ill., plant receives warning letter citing sterilization validation problems in production of Abbott's acute porphyria therapy Panhematin (hemin for injection), following FDA inspection in March. The July letter comes one year after Abbott's parenteral manufacturing plant in North Chicago received a warning letter relating to GMP deviations in its aseptic manufacturing process (1"The Pink Sheet" Nov. 29, 1999, p. 28). Abbott's diagnostic division is operating under a GMP consent agreement signed in November 1999