4 Observations in BSO Inspection

FDA has released the FDA-483 issued following a 3/1-1/11 inspection at BSO, a Lakewood, CO, outsourcing facility. The form’s four inspection observations were: 

•          written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up;
•          procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance;
•          the labels of the outsourcing facility’s drug products do not include information required by regulations; and
•          the firm compounds drugs that are essentially a copy of one or more approved drugs within the meaning in sections of the Federal Food, Drug, and Cosmetic Act.