483
SHINE Technologies, LLCSHINE Technologies, LLC – FDA 483, Jul 10, 2026
Record Details
An FDA inspection of SHINE TECHNOLOGIES LLC in Janesville, WI, revealed a critical failure to adequately validate written procedures for equipment and surface sanitization. Inspectors observed residue in both CNC and Grade C production areas, indicating a lack of control over microbial contamination in a sterile processing environment. This raises concerns about the firm's ability to maintain aseptic conditions for drug substance manufacturing.
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