FDA 483 - Defender SD Manufacturing LLC - September 22, 2022

Defender SD Manufacturing LLC in San Diego, CA, was cited with five observations on a Form 483, indicating significant deficiencies across its quality control, production, and laboratory systems. The firm failed to ensure adequate QA oversight of laboratory records, lacked proper written procedures for environmental monitoring trending, and exhibited insufficient qualification and monitoring of aseptic processing areas. Additionally, the inspection revealed incomplete laboratory documentation and failures in equipment calibration and qualification, highlighting a serious lack of control over critical manufacturing and testing processes.