483
Janssen Ortho LLCJanssen Ortho LLC – FDA 483, Feb 22, 2016
Record Details
Janssen Ortho LLC in Gurabo, PR, received a Form 483 with three observations related to manufacturing drug products. The inspection revealed deficiencies in the routine maintenance of automated control systems, inadequate computer system controls for record changes, and a lack of proper records and procedures for equipment maintenance and cleaning. These issues indicate a moderate level of concern regarding quality system oversight and data integrity.
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ID · fb129a2c-9d30-477a-b2cc-7094454a5404
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