European regulators are taking quick action against an Italian CDMO after they found what they called major deficiencies in its production of sterile drugs.
The European Medicines Agency pulled the manufacturing certificate for sterile production at a Lampugnani Farmaceutici plant in Nerviano, Italy, following an inspection in May. The Italian Medicines Agency recommended that EU countries recall any sterile product they have received from Lampugnani and halt any more imports until the plant is brought back to GMP standards, unless they have no alternative supplies.
In its letter posted on the EudraGMDP website, regulators said major deficiencies were found in monitoring the controlled contamination areas as well as in equipment. There were also problems with microbiological quality-control testing.
It said the problems don’t affect the company's production of nonsterile drugs and finished products. The Italian agency said the company’s plan for correcting the problems has been approved but that it will do a follow-up inspection and that until problems are fixed countries should suspend imports from the drugmaker.
The action comes shortly after the EMA pulled the manufacturing certificate of a sterile drugmaker in Taiwan. In May, the EMA, on the recommendation of U.K. inspectors, pulled the license of Savior Lifetec Corp. in Chunan Chen, Miaoli County, in Taiwan after an inspection in March turned up a variety of problems. It also recommended that the sterile drugmaker recall all batches of APIs from EU markets that are not considered essential. It has told the company not to ship more product until it can return to compliance.