FDA 483 - ECI Pharmaceuticals, LLC - February 27, 2015

ECR Pharmaceuticals LLC, a prescription oral drug manufacturer in Ft Lauderdale, FL, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate production and process controls, unapproved changes to specifications by the quality unit, incomplete master production and control records, and non-representative sampling of active pharmaceutical ingredients. These issues indicate a lack of robust quality assurance for drug product identity, strength, quality, and purity.