Alexion issued new FDA Form 483 for Rhode Island plant

The FDA has again raised issues at an Alexion plant that three years ago was issued a warning letter. The facility is where Alexion manufactures what has been deemed the world’s most expensive drug, Soliris.

Alexion ($ALXN) filed an 8-K with the SEC on Monday saying that the FDA issued a Form 483 with three observations following a recent inspection of the Smithfield, RI, manufacturing plant, a facility with a history of manufacturing lapses. The Cheshire, CT-based company said the observations related to “closure of certain investigations, validation of surface sampling methods, and monitoring of water systems.”

It said none of the observations were designated as a repeat observations and that it will work “diligently to address the observations.”


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Alexion continues to manufacture Soliris at the plant and said that it doesn’t anticipate that supply will be interrupted for the orphan drug. Soliris, which can run up to $400,000 a year, treats the life-threatening blood disorder paroxysmal nocturnal hemoglobinuria, a disease that only affects about 8,000 Americans. In its Q2 earnings release July 28, the drugmaker reported second-quarter revenues of Soliris were up 10% to $701 million on a 15% growth in volume.

In 2013, Alexion was issued a warning letter for the Rhode Island plant after the FDA found the company had not thoroughly investigated "bacterial contamination of certain batches," as well as other cGMP issues. In that case, the FDA noted some repeat problems from a visit the year before. It later had problems with a contractor filler and had to recall some lots of Soliris. Then, in 2014, the Rhode Island plant was cited with more observations in a follow-up inspection.

In the filing Monday, Alexion said that it has continued to work on its quality program.

- here’s the 8-K
- here's its earnings release 

Related Articles: 
Alexion gets warning letter for Soliris plant 
Alexion recalls more Soliris 
Alexion gets new Form 483 in follow-up inspection 
Alexion making €100M Ireland plant investment


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