The worst is over for a CordenPharma Latina sterile manufacturing plant in Italy that was slapped last year with an FDA warning letter. The FDA has now given it a green light.
The Germany-based CDMO announced that the FDA issued a closeout letter for the plant near Sermoneta, Italy, effective Aug. 15.
The company said the company has always been dedicated to quality but to make sure its approach is effective, it has “planned a long-term high investment program in regards to corporate and quality systems, organizational structure and infrastructure, including a process to involve customers in improving transparency.”
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The facility, which the company acquired from Bristol-Myers Squibb in 2010, was issued the warning letter last year, following an inspection in 2015 that uncovered a host of concerns in its aseptic filling area. Problems included what the FDA said was “Black grime and filth” in tiles that it said raised the potential for microbial contamination.
CordenPharma is the contract manufacturing arm of ICIG, an EU holding company that has operations in pharma and chemicals. It has been steadily expanding, generally by buying up the closed operations of other drug companies. It has about 30 manufacturing plants across Europe and the U.S.
ICIG last year picked up a Sandoz intermediates plant in Germany that Novartis put on the block after Asian competition drove down prices for its products. The CDMO took on the plant and its 270 workers.