# FDA 483 - Steuart Contract Packaging - May 07, 2026

Source: https://www.keypedia.com/records/483/steuart-contract-packaging/60456cbc-63da-4800-88fb-f8648c49c1b3

> FDA 483 for Steuart Contract Packaging on May 07, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steuart Contract Packaging
- Inspection Date: 2026-05-07
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Steuart Custom Products, Inc. in Le Roy, MN, a drug manufacturer, revealed significant deficiencies across multiple systems. The firm failed to adequately validate cleaning processes for shared equipment, qualify upgraded manufacturing equipment, and implement proper controls for computer systems to ensure data integrity. Additionally, the environmental monitoring program was found to be insufficient for preventing objectionable microorganisms in non-sterile drug products.

## Related Officers

- [Elizabeth R. Bloom](https://www.keypedia.com/people/elizabeth-r-bloom/51c7ec4e-97bb-4543-adc3-cf02d335f159)

Company: https://www.keypedia.com/companies/steuart-contract-packaging/16fe498b-d311-45f2-a2f4-f60d7445a4ed

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