www.fdanews.com/articles/176943-fda-slaps-janssens-continuous-production-line-with-form-483
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FDA Slaps Janssen’s Continuous Production Line With Form 483
June 7, 2016
A Janssen production plant that turned heads for its continuous production line was handed a 483 two months prior to switching the line from batch production.
The 483 issued in late February documents a pre-approval inspection, citing three issues, at least one of which concerned recordkeeping for the continuous production line established in the company’s plant in Gurabo, Puerto Rico.
The company said that it responded to the 483 findings with a plan to address the inspectors’ concerns, which the FDA accepted prior to approving the production change.