CordenPharma last year got FDA approval to produce sterile products at a plant in Italy. Now, it has gotten an FDA warning letter for a host of issues for its aseptic filling, including the fact the FDA doesn't like the plant's design when it comes to sterile production.
The FDA today posted the warning letter, which came as a result of in inspection in May 2015. The Massachusetts-based contractor said today that it is giving issues complete attention and will respond to the FDA with a comprehensive plan within the stipulated timeframe of 15 days. It said neither APIs nor finished dosage forms from CordenPharma Latina are affected.
Among other problems inspectors criticized the design of the plant, saying drains in the aseptic manufacturing area create the potential for microbial contamination. It also spanked the facility for having cracked tiles in the sterile area and said simply sealing them was not good enough. It asked for timeline for when the floors would be replaced.
"Black grime and filth were visible in the tile (b)(4) throughout the aseptic area, including in the direct vicinity of the manufacturing equipment," the letter reads. "Furthermore, cracked and inadequately repaired floor tiles created more gaps to hold filth."
It also said the company's test procedures for API were not "scientifically sound."
The drugmaker said in a statement that it will be talking with its customers to “discuss the scope and effects of the warning letter, highlight the remediation steps already taken since the inspection and relay CordenPharma’s ongoing strategy for effective response.”
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 closed operations of other drug companies. It says it currently has 29 manufacturing plants across Europe and the U.S. In the past it has acquired plants from AstraZeneca ($AZN), Bristol-Myers Squibb ($BMY), Genzyme and Roche ($RHHBY).
- read the warning letter
- here’s the release
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