Alexion Pharma (ALXN) Receives FDA Form 483 for Smithfield, RI, Facility
- Wall St. rises amid robust earnings, GDP data
- FBI to review more emails related to Clinton's private email use: letter
- Unusual 11 Mid-Day Movers 10/28: (GRVY) (VRTS) (ITGR) Higher; (OPXA) (SNMX) (STON) Lower
- ExxonMobil (XOM) Tops Q3 EPS by 5c; CapEx Light of Views
- Baker Hughes (BHI), General Electric (GE) in Partnership Talks, Not Merger Talks
Get the Pulse of the Market with StreetInsider.com's Pulse Picks. Get your Free Trial here.
Alexion Pharma (NASDAQ: ALXN) disclosed the following on Monday:
Item 8.01 Other Events.
The U.S. Food and Drug Administration (FDA) recently completed a routine current Good Manufacturing Practice (GMP) inspection of Alexion Pharmaceutical, Inc.'s (Alexion's) Smithfield, Rhode Island manufacturing facility. At the conclusion of the inspection, the FDA 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. As previously disclosed, Alexion received an FDA Warning Letter, dated March 22, 2013, regarding compliance with current GMP at the Rhode Island facility. None of the observations in the current Form 483 were designated as a repeat observation.
Addressing FDA observations and advancing quality initiatives continues as a key priority for Alexion and Alexion has enhanced and expects to continually enhance its overall quality program. Alexion will work diligently to address the observations identified in the current Form 483.
Alexion continues to manufacture products, including Soliris® (eculizumab), in this facility. Based on current information, Alexion anticipates that the supply of Soliris to patients will not be interrupted.
Further, based on current information, Alexion does not anticipate there will be any material financial impact to address the observations and resolve outstanding FDA concerns.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- UPDATE: Alexion Pharma (ALXN) Shares Whipsawed on Erroneous Headline
- St. Jude Medical (STJ) Announces FDA Approval, U.S. Launch of Medical Device to Reduce Risk of Recurrent Ischemic Stroke in Patients with PFO
- Opexa Therapeutics' (OPXA) Phase 2b Abili-T Trial of Tcelnaa in Secondary Progressive MS Misses Primary Endpoint
Create E-mail Alert Related CategoriesCorporate News, FDA, Litigation
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!