The positive reclassification of the facility in Guayama, Puerto Rico, comes after moves by Wyeth to address compliance concerns expressed by the FDA in a warning letter issued in May last year. The agency carried out the re-examination of the site following several deviations from current good manufacturing practices (cGMP) noted during the original inspection in 2006.
Particular concerns were raised regarding manufacture, processing, packaging and field alert reporting practices at the site. The company was also pulled up on inadequate investigation of "unexplained discrepancies or out of specification results" in batches of drug products manufactured at the site, and lack of action on the part of the company to remove certain products from the market during lengthy investigations.
There were also concerns over cleaning and maintenance of the packaging equipment at the facility to prevent contamination of drug products. For example, the FDA warning letter referred to several incidents of consumers reporting screws and washers being found inside bottles of Inderal LA (propranolol hydrochloride) and Effexor (venlafaxine) tablets as a result in ineffective cleaning practices. As well as the contamination issues these cases represented, the agency also noted its concern that "neither [the company's] cleaning procedures nor the line clearance inspections were able to detect that the affected equipment was missing some of its parts."
Manufacturing at the site, however, was not affected nor were there any shortages as a result of the FDA action, even following the news that the inspection would be delayed due to FDA staffing and timetabling problems. This positive reclassification of the manufacturing facility now means that any issues found by the FDA have been dealt with by Wyeth satisfactorily or simply "do not merit any further regulatory action."
The change in status comes at just the right moment, according to chief operating officer and president of Wyeth, Bernard Poussot, as several new products are due to be manufactured at the Puerto Rico site. Already home to production of major Wyeth products such as Effexor (venlafaxine), Protonix (pantoprazole sodium) and Rapamune (sirolimus), the site will also add another four products to its production lines over the next year or so.
The contraceptive drug Lybrel (levonorgestrel/EE), anti-depressant Pristiq (desvenlafaxine succinate), and bifeprunox for schizophrenia/bipolar disorder are all expected to gain approval this year, with Viviant (bazedoxifene) for osteoporosis anticipated to obtain approval next year. With all these new products lined up to be manufactured at the Guayama facility, the positive report from the FDA came at just the right time.
The company reiterated its commitment to maintaining exemplary quality and compliance standards at all of its manufacturing sites following news of the positive facility inspection.