6 Observations in Cipla FDA-483

FDA has released the form FDA-483 issued following a 6/10-6/21 inspection at the Cipla drug manufacturing facility in Goa, India. The observations were:

• failure to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods;
• aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
• aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
• failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
• failure to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel; and
• failure to fully follow the responsibilities and procedures applicable to the quality control unit.