8 Observations on Jubilant HollisterStier Form FDA-483

FDA has released the Form FDA-483 with eight observations from a 6/8-6/17 inspection at the Jubilant HollisterStier drug manufacturing facility in Spokane, WA. The inspection observations were:

• component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality;
• failure to follow written procedures for the storage of components;
• failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up;
• equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use;
• failure to establish the sensitivity of test methods;
• failure of laboratory controls to include the establishment of scientifically sound and appropriate sampling plans designed to assure that components conform to appropriate standards of identity, strength, quality, and purity;
• failure to follow established test procedures; and
• failure to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit.