Food and Drug Administration (FDA) staffing and timetabling problems have delayed the re-inspection of Wyeth's Puerto Rico site, the company said this week.
The delays mean that the agency will not complete the check for at least several more weeks, after initiating the inspection in late January this year.
The FDA is carrying out an examination of the facility following the issue of a warning letter to Wyeth back in May 2006, which documented several deviations from current good manufacturing practice (cGMP) regulations.
Wyeth says that it has undertaken corrective action to address the manufacturing concerns highlighted by the FDA in a bid to improve compliance at the facility. The agency had raised several issues with the company, particularly with regard to manufacture, processing, packaging and field alert reporting (FAR) practices.
The FDA pulled the company 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."
When speaking to In-PharmaTechnologist, a Wyeth representative was keen to point out that manufacturing at the site had not been affected or delayed, and the news of the FDA needing more time to complete the re-inspection would not cause a problem.
At the end of January Wyeth received an approvable letter for Pristiq (desvenlafaxine succinate) for the treatment of major depressive disorder. The drug is due to be manufactured at the Guayama site, on condition of a satisfactory inspection by the FDA.
When asked whether the FDA staffing problems and delays would affect the proposed start date for the manufacture of Pristiq, Doug Petkus of the company stated: "We don't anticipate that the delay will affect any product launches."
The company now foresees the FDA completing its inspection in early April.