Sandoz’s Colorado Facility Flagged for Metal Contamination
The FDA cited a Sandoz facility in Broomfield, Colorado for product contamination with metal particles.
In a Form 483 following an April 8-16 inspection, the agency rapped the facility for failure to fully investigate a complaint involving metallic particles in a methylprednisolone tablet.
The complaint reported particles in one tablet of a 21-day dose pack of methylprednisolone 4mg, a steroid used for treating inflammation, chronic illness flares, severe allergies and other conditions.
The agency criticized the firm for failing to fully evaluate the complaint and for excluding certain drug lots from investigation without a scientific justification.