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FDA clears Mylan: Report finds plant conducted adequate quality investigationAug 14, 2009 (The Dominion Post - McClatchy-Tribune Information Services via COMTEX) -- The U.S. Food and Drug Administration (FDA) has released its report on its investigation into quality control practices at Mylan Inc.'s Morgantown plant. "Our inspection found that the firm appears to have conducted an adequate investigation," said Judy Leon, FDA deputy director for strategy, Office of Public Affairs in an email to The Dominion Post. The FDA visited the Mylan plant July 28 and 29, following news reports that Mylan had conducted an internal investigation of workers allegedly overriding and ignoring computer-generated safety protocols -- called red screens. Leon said the FDA sent its report and a letter to Mylan via overnight mail Wednesday. In her e-mail to The Dominion Post, she summarized the findings of the inspector's report: Mylan "did not find evidence that the lack of adherence to the SOP [standard operating procedure] resulted in adverse impact to the affected product lots." "No data was deleted and the audit trails were intact for each instance where the software was overridden by the operator." "Training was provided to operators and the firm was working with the software company to implement a patch that would disable the function which allowed employees to override data." "This officially closes FDA's investigation; the agency plans no additional action." In a press release issued Wednesday, Mylan Chairman and CEO Robert J. Coury said: "I would like to thank the FDA for thoroughly reviewing this matter. The baseless speculation -- was entirely unnecessary." Coury said in the release, "Mylan's manufacturing facilities -- especially our plant in Morgantown -- have always represented the gold standard when it comes to quality." "Without ever getting complacent, our entire management team and all of our employees continue to demonstrate an unyielding commitment to sustain the highest of quality standards. "I would like to thank all of our employees for their continued hard work and execution, and I am pleased that this investigation is formally behind us." FDA report excerpts The FDA sent a redacted copy of its report to The Dominion Post. Here are some excerpts. "On 7/27/09, I told Mr. Richard D. Glover, Vice President, Quality, that I was conducting a limited inspection concerning allegations that Laboratory Information Management System (LIMS) quality controls had been overridden for weight, thickness and hardness. Mr. Glover stated the firm's investigation found that all the so-called -- red screen incidents involved obvious errors such as broken tablets, tablet or capsule bouncing off the scale, leaning on the chute from the vibratory feeder where no manufacturing equipment adjustments were necessary. He stated that no data was deleted and the audit trails were intact." "Mr. Glover explained that the operators had used the right click feature in LIMS to correct these obvious errors. He stated the right click feature was an electronic version of crossing out a data entry with a single line, initialing the entry, entering the correct data and providing a reason for the correction that was performed when the records were kept by hand on paper. He stated the operators were permitted to use the right click feature to change inaccurate information such as an incorrect box number for the tablets or capsules sampled. He stated that the right click feature is a normal part of the LIMS software. He said Management was not aware that the right click feature could be used to correct red screen data errors until the firm's investigation was conducted." "The firm expanded their investigation and searched for improperly handled red screens back through or approximately [redacted] months. Mr. Glover stated that they found employees that had used the right click feature to make corrections to the physical testing data. He stated they interviewed all employees and determined that they had only used the right click feature to correct the physical testing data when they had witnessed an obvious error." [From inspector's interview with an employee.] "I asked him if he had ever used the right click feature to clear a red screen event. He said he had. I asked him how he had learned about this function. He said it was a basic knowledge of computers. He right clicked on the mouse and found the function was available. I asked him when he used the function; he said he used it when there was an obvious case of operator or instrument error. He said he absolutely knew the product was safe. He said he would only do it when it was so far out that he knew it was not the correct data. He said he did not understand it was wrong until they held the meetings in May. ... I asked him what happened after the company found out that operators were using the right click function to clear red screens. He said the company interviewed him and anyone else who had right clicked. He said in the meeting they let every single employee know what was allowed and what was not. He said it appeared they had changed the LIMS system. He said they had conducted training for all the employees. I asked him if he had tried to see if he could use the right click function since the meetings. He said he had not even looked to see if he could still do it." [Inspector explains his report to Mylan officials.] "I stated I had reviewed improperly handled red screen events from the firm's investigation; spot checked data from previous year for red screen events, the firm's investigation, corrective and preventative action and found no evidence of data deletion. I stated I had found that there were deviations from their written Standard Operating Procedures; however they had performed an investigation and implemented corrective and preventative action. I stated that a form FDA 483 'Inspectional Observations' would not be issued." To see more of The Dominion Post or to subscribe to the newspaper, go to http://www.dominionpost.com/. Copyright (c) 2009, The Dominion Post, Morgantown, W.Va. Distributed by McClatchy-Tribune Information Services. For reprints, email [email protected], call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA. |