Start Date: 2002
Financial penalties: none
End Date: 2004
This case involved nonconformance with GMP practices at a facility in Corona, CA. The consent decree stemmed from a 1999 FDA inspection that uncovered poor training, documentation and lab control practices. The regulator wanted assurance that once corrections had been made, the plant would remain compliant with cGMP regulations in the future.
Watson had hired cGMP-compliance consultancy KMI/PAREXEL for the QA overhaul in 2000. No product manufacturing was suspended. Watson added 30 employees to its quality assurance department.