Pfizer plant in Kansas repeatedly hit with form 483 infractions

Dec. 11, 2018

The U.S. Food and Drug Administration has issued eight Form 483 citations at Pfizer's McPherson, Kansas plant since 2012 after a follow-up inspection from July and August. The FDA had sent Pfizer a warning letter last February regarding GMP violations and poor asceptic processing.

The FDA noted failures to properly investigate mold contamination that led to finished product being rejected, inadequate procedures in preventing microbial contamination, subpar cleaning and disinfecting procedures and the inappropriate use of manufacturing, processing and packaging equipment.

Read the full FDA form