6 Observations on Right Value FDA-483

FDA has released the Form FDA-483 issued following an 8/24-9/8 inspection at Right Value Drug Stores, an Irving, TX outsourcing facility. The six inspection observations were:

• failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
• failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
• failure to fully follow the responsibilities and procedures applicable to the quality control unit;
• failure to thoroughly review any unexplained discrepancy, whether or not the batch has already been distributed;
• aseptic processing areas are deficient regarding the system for monitoring environmental conditions; and
• test devices are deficient in that instruments not meeting established specifications are used.