Mylan Is Warned Over Plant In Puerto Rico

Mylan Is Warned Over Plant In Puerto Rico

November 28th, 2011 // 1:16 pm @

As the FDA attempts to toughen its oversight of manufacturing facilities in far away lands, plants in Puerto Rico are also undergoing added scrutiny. The latest example is a San Juan plant operated by Mylan Laboratories, the generic drugmaker, which received a warning letter last month for significant violations of good manufacturing practices.

An FDA inspection earlier this year found that Mylan failed to complete a required test meant to ensure uniformity of the contents of its drugs, and did not thoroughly investigate or explain why a batch of medication or its components did not meet specifications, according to the October 13 letter (which you can read here).

As such letters go, this one is rather brief. Nonetheless, the missive was sent as the FDA is under sustained pressure to beef up enforcement of pharmaceutical plants, especially in the wake of two infamous scandals – the Heparin debacle in which contaminated ingredients from China led to more than 80 deaths in the US and the Johnson & Johnson imbroglio in which the agency was accused of conducting lax oversight of a facility in Puerto Rico that circumvented regulations (back stories here and here).

The warning letter also follows the recent publication of a study that found drugs made in plants in Puerto Rico that are owned by US drugmakers were more likely to have quality problems than those made by the same drugmaker at a similar plant in the US. The study was published in Journal of Operations Management (back story).

Nonetheless, one analyst does not believe the letter to Mylan is symptomatic of larger problems. In an investor note, Shibani Malhotra of RBC Capital Markets writes that he spoke with Mylan management and they insisted they impact is immaterial to their operations. And he appears inclined to agree, given that the facility is relatively small seen in the context of global manufacturing.

“The FDA has not precluded any production from the plant and as such, this will be uninterrupted going forward,” he writes. “Mylan has no near-term product approvals that are dependent on the plant. (And) the FDA has only highlighted two issues that need to be fixed, both of which seem relatively easy to do and Mylan is committed to resolving these ASAP.”

In short, he continues, “they have no reason to believe this warning letter will trigger inspections at any of their other manufacturing facilities. The FDA regularly visits all of their global facilities and they do not anticipate change to this process.” He adds that there are no outstanding 483 inspection reports pertaining to the key Morgantown, West Virginia, facility run by Mylan.


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