The US FDA observed potential mold contamination and deficient aseptic processes during an inspection at Pfizer’s fill/finish facility in McPherson, Kansas.
The McPherson facility was one of several manufacturing plants added to Pfizer’s network following the $17 billion (€14.9 billion) acquisition of Hospira in 2015.
The plant has been subject to various regulatory issues, resulting in a US Food and Drug Administration (FDA) warning letter in February 2017 citing poor aseptic processing and repeat GMP violations.
An October 2017 inspection resulted in the plant being upgraded to Voluntary Action Indicated (VAI) status, but the FDA has now published results of a follow-up inspection from July and August this year in a Form 483 with eight repeat observations.
These included failures to properly investigate mold contamination that led to an undisclosed number of batches of finished product being rejected; inadequate procedures in preventing microbial contamination; deficient cleaning and disinfecting procedures; and the inappropriate use of manufacturing, processing, and packaging equipment.
“Following the July-August 2018 inspection, the site developed and implemented a robust corrective and preventive action plan to address FDA observations noted during the inspection. While there is still additional work to be done against our plan, the site has made significant improvements and progress since the inspection,” Pfizer said in a statement sent to this publication.
“We will continue tofocus on executing improvements at the site and bringing safe and effective medicines to our patients. In the interim, our site remains in operation and we stand behind the products manufactured there.”
Regulatory issues have already caused Pfizer approval delays, for example the firm’s biosimilar version of Amgen’s Epogen (epoetinalfa), Retacrit, received a complete response letter (CRL) in June 2017 citing the problems at McPherson. Retacrit received approval on the second try in May 2018.