# FDA 483 - Creative Werks LLC - January 22, 2026

Source: https://www.keypedia.com/records/483/creative-werks-llc/2d4819fd-d1ab-44ee-95f5-da404d952295

> FDA 483 for Creative Werks LLC on January 22, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creative Werks LLC
- Inspection Date: 2026-01-22
- Product Type: drugs
- Office Name: FDA District Office — Chicago, Illinois
- Summary: Creative Werks LLC, an OTC drug product labeler/packer in Elk Grove Village, IL, was cited for significant deficiencies in its quality system. The inspection revealed a widespread failure to establish written procedures for critical aspects of drug product manufacturing, including production, process controls, packaging, labeling, quality control, warehousing, and change control. Additionally, the firm's employees lacked adequate drug-specific cGMP training, leading to documentation errors and quality holds related to incorrect labeling.

## Related Officers

- [Angela C. Welker](https://www.keypedia.com/people/angela-c-welker/b732b19f-c8e8-43b0-bc81-8dcde8a53c84)

Company: https://www.keypedia.com/companies/creative-werks-llc/264a3311-d715-48f2-8921-55b81b382d09

Office: https://www.keypedia.com/offices/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65