Drugs

28-Page FDA-483 for Edge Pharma Inspection

FDA has released a 28-page FDA-483 with 13 observations from a 9/20-11/30/21 inspection at Edge Pharma, a Colchester, VT, outsourcing facility. The inspection observations were:

buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair;
failing to thoroughly review any unexplained discrepancy and 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;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
failing to write and follow test procedures relative to appropriate laboratory testing for sterility;
failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable systems to facilitate cleaning, maintenance, and proper operations;
failing to write and fully follow responsibilities and procedures applicable to the quality control unit;
failing to perform routine calibration, inspection, and checking of automatic and mechanical equipment according to a written program designed to assure proper performance;
failing to follow the written stability testing program;
failure of the written stability program for drug products to include reliable and specific test methods;
failing 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
the labels of the outsourcing facility’s drug products are deficient.

Many of the observations were repeated from one or more of three previous inspections, the form says.

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