PharmaFab revises manufacturing procedures

Executive Summary

PharmaFab is revising its standard operating procedures for manufacturing following FDA 1warning letter. The June 15 letter followed inspection of PharmaFab's manufacturing facility in Grand Prairie, Tex. from Jan. 5 through Jan. 14. FDA's citations include inadequate procedures for handling reprocessed batches, conducting stability tests and preventing of objectionable microorganisms in drug products not required to be sterile. FDA noted that PharmaFab's responses were sufficient for five of the eight issues listed in the warning letter...