The drugmaker says the FDA has finally completed a re-inspection of its plant in Guayama, Puerto Rico, which was triggered by a May 2006 warning letter, but there are still some unspecifed outstanding issues and maybe there will be a resolution in the “near future.”

“Based on the nature of the inspection observations, Wyeth is hopeful that it can respond to the remaining concerns and that the agency will be able to determine in the near future that the Warning Letter issues have been satisfactorily resolved,” reads the carefully crafted statement. “Wyeth intends to respond in writing to the observations…no later than mid-April and then will seek to continue its discussions” with the FDA about overall compliance.

Bernie Poussot, Wyeth’s vice chair, tries to sound optimistic: “The conclusion of this inspection is an important step…The company believes we are in a position to submit adequate responses to the inspection observations.”

On a good note, the EMEA inspected the plant last week and Wyeth claims the inspecion was successful, with “no critical or major observations and Wyeth received a positive evaluation of the site’s compliance status.” A progress report will be given during the April 19 earnings call.

This is taking longer than most expected. And this means delays in getting new meds to market. But Wyeth has a history of quality-control problems at various plants, yielding one consent decree. The FDA ought to take a hard line and force the company to adhere to standards. Such an approach is long overdue.

Wyeth’s statement.[tags]FDA, Manufacturing. Puerto Rico, Wyeth[/tags]