SCA Pharmaceuticals’ FDA-483 Released

FDA has released the FDA-483 issued following a 9/25-9/29/17 inspection at SCA Pharmaceuticals, a Little Rock, AR, outsourcing facility. Specific inspection observations were: 

•          aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
•          there is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed;
•          clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform;
•          procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process;
•          aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions; and
•          the labels of the outsourcing facility’s drug products are deficient.