cGMPs

Fresenius Kabi Fined for Fatal Insulin Manufacturing Deficiency

Source: BBC

Jul 14, 2015

Fresenius Kabi and sister firm Calea UK have been fined a total of $844,600 following the death of a diabetic hospital patient injected with insulin syringes containing no insulin.

The patient suffered multi-organ failure triggered by diabetic ketoacidosis because his body was deprived of insulin for more than 13 hours.

This incident -- as well as an additional incident in 2011 that involved pre-prepared syringes containing three times the prescribed dose -- followed a series of inspections by the UK's Medicines and Healthcare products Regulatory Agency that highlighted manufacturing deficiencies at the Calea and Fresenius Kabi site.

Fresenius Kabi is also on the U.S. FDA's radar. In February 2012, the U.S. FDA issued a warning letter to Fresenius Kabi's New York facility for GMP violations. In July 2013 the FDA issued a warning letter to Fresenius Kabi's API plant in INdia for data manipulation issues.

Read the BBC release