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# SCA Pharmaceuticals’ FDA-483 Released
- URL: https://www.fdaweb.com/sca-pharmaceuticals-fda-483-released/
- Published: 2018-01-04T12:00:00.000Z
- Updated: 2026-09-14T23:11:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140414

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.