Fresenius Kabi, which has faced any number of actions by the FDA over manufacturing issues, is now having to cough up a substantial amount of money in the U.K. Fresenius Kabi and a sister company have been penalized £550,000 after a court found that manufacturing lapses were tied to the death of a patient in a U.K. hospital.
Neil Judge died in a Sheffield hospital of organ failure triggered by diabetic ketoacidosis because syringes manufactured by Calea and sold by Fresenius contained no insulin, the Medicines & Healthcare products Regulatory Agency (MHRA) said last week in a statement. He died of organ failure triggered by diabetic ketoacidosis after going 13 hours without insulin.
On top of that, the court found that Fresenius and Calea also supplied tobramycin syringes used on another patient that contained three times the prescribed daily dose. Fresenius Kabi was fined £500,000 ($767,800) after being convicted of medicinal failure for its part in the 2010 death. Calea was ordered to pay £50,000 ($76,800). They were ordered to pay £5,900 ($9,000) each in court costs.
|MHRA enforcement head Alastair Jeffrey|
"Fresenius Kabi Ltd and Calea UK Ltd are equally responsible for the medicinal failure that was a major contributing factor in the tragic death of Neil Judge, who was deprived of the vital insulin his body needed because of a serious manufacturing error," Alastair Jeffrey, MHRA head of enforcement, said on Thursday in a statement.
In the other incident, the government said that Calea had manufactured a batch of prefilled syringes of infection fighter tobramycin that were prepared for a specific cystic fibrosis patient being treated at the Royal Shrewsbury Hospital in 2011. The court heard that the syringes were found to have three times the daily dose after the patient reported a "fizzing sensation." The government said the patient had no lasting effects but was fortunate he did not suffer more serious effects.
"I hope this case serves as a clear reminder to others, as MHRA will not hesitate to take enforcement action when serious failings occur," Jeffrey said.
The FDA has also had issues with Fresenius Kabi, issuing a warning letter in 2013 for a plant in India where it said employees had lied about having blended APIs that failed quality tests into batches that passed in an effort to hit specifications. It reported that one employee was seen trying to hide test results about that practice in his pocket. The year before, it sent a warning letter to Fresenius' APP Pharmaceuticals facility in the U.S. for problems that included insect infestations that resulted in bugs being found in a sterile manufacturing area. The agency also called into question the plant's heparin production after seeing a trend of out-of-spec batches.
- here's the Gov.UK release
Fresenius Kabi Indian plant accused of manipulating data
Fresenius gets 2nd warning letter in 18 months
FDA seeks 3 years of heparin test results from APP Pharmaceuticals