5 Observations in Glenmark Inspection

FDA has released the FDA-483 with five observations issued following a 5/14-5/24 inspection at Glenmark Pharmaceuticals, a Madhya Pradesh, India, finished oral solid dose manufacturer. The specific observations were:

•          failing to establish and document the accuracy, specificity, and reproducibility of test methods;
•          failing to have laboratory controls include establishment of scientifically sound and appropriate sampling plans designed to assure that products conform to appropriate standards of identity, strength, quality, and purity;
•          failing to thoroughly review any unexplained discrepancy, whether or not a batch has been already distributed;
•          failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel; and
•          failing to fully follow the responsibilities and procedures applicable to the quality control unit.