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FDA says it is continuing with probe into Generics Mylan plant
 
 
  by Anna Bratulic firstword.com
 
The FDA said Tuesday that an investigation into alleged quality-control violations at a Mylan drug manufacturing plant is ongoing. The comment followed a statement issued by Mylan earlier in the day which claimed the agency visited the West Virginia site on Monday and determined that accusations reported in a recent Pittsburgh Post-Gazette article were "unfounded."
 
In its statement, Mylan said it brought the allegations of quality-control deviations to the attention of the FDA, which visited the plant and then "noted there was no evidence of any data deletion." According to Mylan, the regulator stated that "all data was reviewed and was present and accounted for." Furthermore, Mylan remarked: "The agency agreed that this was a minor standard operating procedures deviation that existed, was fully investigated, and all corrective actions were fully implemented by Mylan."
 
However, Steven Solomon, the FDA's assistant commissioner for compliance policy in the Office of Regulatory Affairs, confirmed that an investigation is continuing "and the agency has formed no conclusions at this time. Statements to the contrary are untrue." He noted that the probe "involves allegations of compliance violations that the FDA takes very seriously."
 
Commenting on the FDA's response, Mylan spokesman Michael Laffin suggested the opposing statements could be due to a timing issue in regards to the local inspector reporting back to the agency. "Our CEO would have never gone out with a statement without being informed of a close-out on the FDA inspection," he said.
 
Reference Articles
 
US FDA says probe of Mylan plant ongoing - (Forbes)
 
Mylan rebounds on FDA thumbs up - (MarketWatch)
 
FDA says investigation into Mylan facility is ongoing - (Morningstar)
 
Mylan reports that the FDA determined that all accusations were unfounded - (Mylan)
 
Mylan, FDA disagree on quality control inquiry - (Yahoo!Finance)
 
 
 
 
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