# SHINE Technologies, LLC – FDA 483, Jul 10, 2026

Source: https://www.keypedia.com/records/483/shine-technologies-llc/bde67bbc-4ce9-4428-a7ae-ef65e998ea8a

> FDA 483 for SHINE Technologies, LLC on July 10, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SHINE Technologies, LLC
- Inspection Date: 2026-07-10
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Vaishali J. Patel](https://www.keypedia.com/people/vaishali-j-patel/3d515b84-e0fd-4f96-914c-f7f09e2de307)

Company: https://www.keypedia.com/companies/shine-technologies-llc/dbf946e4-9fcf-4d69-b8f3-bb6da7bec474

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d