Alexion gets new Form 483 in follow-up inspection

Alexion's Smithfield, RI, manufacturing facility--Courtesy of Alexion

Despite the best efforts of Alexion ($ALXN), the FDA has lingering concerns about manufacturing of the drugmaker's orphan drug Soliris at a plant in Rhode Island. The drugmaker said the FDA presented it with a Form 483 with new observations following a follow-up inspection of the plant last week. The announcement comes even as the drugmaker is in the midst of recalling 9 lots of Soliris because of possible particulate contamination.

The drugmaker said in a securities filing Monday that the FDA left the document Friday after a 5-day inspection at the Smithfield, RI, facility. The drugmaker did not release the Form 483 but said the observations had to do with a need for better training around gowning procedures, the need for more frequent environmental monitoring, and "processes related to identification of the definitive root cause of a prior bioburden excursion."

Alexion said in the filing that none of the observations were repeats from the warning letter issued to the plant in March 2013. The drugmaker said it continues to manufacture drugs at the facility, including Soliris, its $400,000-a-year product approved for patients with either of two very rare conditions, paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome. Based on what it knows right now, Alexion said it didn't expect any interruption in supply.

Last year's warning letter was issued after Alexion ran into problems with bacterial contamination at the plant. The following month Alexion brought in a team of experts to help and has told analysts it believes it has already addressed the problems highlighted by the FDA.

But in the past year, the drugmaker has recalled more than 95,500 vials of the injected drug because of particulate contamination. The Cheshire, CT-based drugmaker said that it found "visible proteinaceous particles" in a single lot during periodic testing but decided to recall 8 more lots because they were manufactured using the same process that the drugmaker now believes caused the problem.

- here's the SEC filing

Special Report: Top 20 orphan drugs by 2018 - Soliris