JANSSEN ORTHO LLC
Overview
JANSSEN ORTHO LLC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering RIVAROXABAN 10 MG FILM COATED TABLETS.
Core services & business areas
API / Drug Master Files
JANSSEN ORTHO LLC holds 1 active (1 total) FDA Type II Drug Master File — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- RIVAROXABAN 10 MG FILM COATED TABLETSActive2008-07-24
FDA compliance signals
19 FDA enforcement records linked to this company.
- 4832023-03-28
Approve or reject components, products
- 4832023-03-28
Investigations of discrepancies, failures
- 4832023-03-28
Equipment construction - reactive surfaces
- 4832018-08-28
Control procedures to monitor and validate performance
- 4832018-08-28
Scientifically sound laboratory controls
- 4832018-08-28
Investigations made into any unexplained discrepancy
- 4832017-05-26
Complaint Handling Procedure
- 4832017-05-26
Procedures not in writing, fully followed
- 4832017-05-26
Calibration/Inspection/Checking not done
- 4832017-05-26
Investigations of discrepancies, failures
- 4832017-05-26
Scientifically sound laboratory controls
- 4832017-05-26
Complete test data included in records
- 4832017-05-26
Computer control of master formula records
- 4832017-05-26
Written procedures not established/followed
- 4832017-05-26
Following/documenting laboratory controls
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