FDA 483 - Teva Puerto Rico LLC - March 03, 2017

An FDA inspection of Warner Chilcott Company LLC in Fajardo, PR, revealed two significant observations related to manufacturing practices. The firm failed to follow established procedures for stability sample packaging and lacked adequate procedures to prevent microbiological contamination during in-process sampling of non-sterile drug products. These deficiencies indicate a need for improved adherence to and establishment of robust quality control procedures.