Mylan's 'red screen' timeline
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Mylan's Morgantown plant is equipped with a computer system that alerts workers when drugs they are making may not meet specifications for weight, thickness and hardness. Deviations may mean the drug contains too much or too little medication or may not work the way it is designed to work.
The alerts are known as "red screens," which halt production until a supervisor is called in to determine whether there is a problem and if so identify it and resolve it. When there is a warning that a drug may be out of specification, the FDA requires that a thorough investigation be conducted and documented.
According to a Mylan internal report, production workers ignored the FDA-mandated protocol, clearing red screens on their own, deleting the record and keeping production rolling. The practice was "pervasive," according to the report, and was only discovered when a supervisor examined a separate record of red screen incidents.
Here's a chronology of what happened after that, based on Mylan's report:
May 11: A quality control supervisor on the midnight shift runs a report and discovers that a technician cleared a red screen for a production worker, who did not report the incident to his supervisor.
May 12: An investigation of the incident begins.
May 15: A quality control technician tells company investigators that employees have been clearing red screens for two years by using "the right click function" on their computers. The report states the employee "feels that the supervisors may be aware of what's going on because they are present in the labs."
May 19: An anonymous caller to Mylan's ethics and compliance hot line alleges that seven managers and supervisors at the plant gave computer passwords to production employees, who used them to clear red screens and continue making drugs without fixing the problem that caused the red screen.
May 19: A quality control supervisor tells investigators she feels the unauthorized clearing of red screens "started off as an accident and then it had just become something that they did daily in their job duties." A quality control technician says she was shown the right click function and that the atmosphere at the plant was "conducive" to using it, the internal report states.
May 20: A quality control technician is confronted with evidence he improperly deleted red screens on two occasions in April. He denies the accusation, telling the company: "This had to occur when he was logged on and possibly someone else had used his computer."
May 22: Mylan closes its investigation of the May 11 incident, concluding that the unauthorized practice of clearing red screens "is a pervasive process that was going on on all three shifts." Investigators also conclude "the quality of the product is not affected." A production worker and technician are given 15-day suspensions.
First Published July 26, 2009 12:00 am