483
Janssen Ortho LLCFDA 483 - Janssen Ortho LLC - May 18, 2016
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Record Details
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.
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ID · c55dee69-a80a-4c80-b7a1-659066e15196