10-Page Eugia Steriles FDA-483

FDA has released the 10-page Form FDA-483 issued following a 6/10-6/19 inspection at the Eugia Steriles Private Limited sterile drug product manufacturing facility in Andhra Pradesh, India. The five inspection observations were:

• failure to establish and follow written procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
• failure to ensure that procedures designed to prevent microbiological contamination of drug products purporting to be sterile include adequate validation of the aseptic process;
• failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
• failure of written records of investigations into unexplained discrepancies to always include the conclusions and follow-up; and
• failure to establish the reproducibility of test methods.