FDA 483 - Janssen Ortho LLC - May 18, 2016

Janssen Ortho L.L.C. in Gurabo, PR, was issued a Form 483 following an inspection from May 11-18, 2016, for deficiencies in its quality control unit. Operators incorrectly calculated average weights in master batch records for Canagliflozin/Metformin drug products. This significant error went undetected by quality assurance during their audits, indicating a failure in oversight and record review.