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# FDA Issues Alexion with Form-483 After Inspection
- URL: https://www.fdaweb.com/fda-issues-alexion-with-form-483-after-inspection/
- Published: 2016-08-08T12:00:00.000Z
- Updated: 2026-09-14T21:22:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136439

FDA has issued Alexion Pharmaceutical a three-item Form-483 after inspecting its Smithfield, RI manufacturing facility. “These observations are inspectional, and do not represent a final FDA determination of compliance,” the company said in a [financial disclosure filing](http://ir.alexionpharm.com/secfiling.cfm?filingID=899866-16-331&ref=fdaweb.com). “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.” Alexion further says the inspection findings should not impact any manufacturing at the facility.