Symbios Risk Analysis, CAPAs Bring Form 483

September 13, 2013
Symbios Medical Products failed to revalidate its manufacturing process for modified flow restrictor subassemblies (FRSAs) used in infusion pumps after it corrected an issue, a Form 483 says. In April 2012, an accidental overfill during release testing led to failure of a FRSA that had been manufactured with the original method. This, in turn, led to rapid emptying of the pump contents.
The GMP Letter