Regulatory Focus™ > News Articles > FDA Issues Form 483 for Alexion’s Rhode Island Site

FDA Issues Form 483 for Alexion’s Rhode Island Site

Posted 08 August 2016 | By Zachary Brennan 

FDA Issues Form 483 for Alexion’s Rhode Island Site

Rare disease drugmaker Alexion disclosed late Monday in an SEC filing that the US Food and Drug Administration (FDA) recently completed a routine current Good Manufacturing Practice (GMP) inspection of the company’s Smithfield, Rhode Island manufacturing facility and issued a Form 483 with three observations.

“These observations are inspectional, and do not represent a final FDA determination of compliance. The observations pertain to: completion and closure of certain investigations, validation of surface sampling methods, and monitoring of water systems,” the company said.

The Form 483 comes more than three years after FDA issued a warning letter to the same manufacturing site, which produces the company’s immunosuppressant Soliris (eculizumab), among other products.

In the warning letter, FDA said that at least six lots of Soliris API were contaminated with Bacillus thuringiensis to the extent that investigators were unable to count the exact number of colonies.

FDA said it was particularly concerned that Alexion "did not conduct an adequate assessment of the impact of this contamination on your final product, including the potential for non-host cell particle contamination, and you did not evaluate the ability of your manufacturing process to clear non-host cell impurities."

An additional lot was found to be contaminated with Acinetobacter redioresistens, FDA said. While Alexion had moved to introduce cleaning agents to decontaminate its clean room, the company never verified its effectiveness before resuming production of its Soliris API. In another instance, two API lots of Soliris were found to have not met pre-specified limits for quality and safety, but were released by staff without "adequate scientific justification," FDA wrote.

However, none of the observations in the Form 483 disclosed on Monday were designated as a repeat observation, Alexion said, noting that it will continue to manufacture products at the facility and it anticipates that the supply of Soliris to patients will not be interrupted.

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