Drugs

14 Observations in Kilitch India FDA-483

FDA has released the 20-page form FDA-483 issued following a 10/12-10/20 inspection at Kilitch Healthcare India, a sterile drug manufacturing facility in Navi, Mumbai, Maharashtra, India. The 14 inspection observations were:

failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failure of laboratory records to include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards;
failure of procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic process;
failure of laboratory controls to include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
failing to maintain in a clean and sanitary condition buildings used in the manufacture, processing, packing, or holding of drug products;
failing to document established test procedures at the time of performance;
failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed;
failing to have batch production and control records include complete information relating to the production and control of each batch;
failing to have the written stability program for drug products to include meaningful test methods;
failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions; and
failure of the quality control unit to review and approve changes to written procedures.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome