_Incident · Regulatory action_

# FDA issues warning letter to Reckitt/Mead Johnson Nutrition over infant formula manufacturing violations at Zeeland and Wanamingo facilities

Canonical ID: `423408bc-c4a6-4b0f-bd75-2c2c5d3fecf6`

- **Occurred:** 2023-08-30
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [Reckitt](/companies/reckitt.md) (id: `a46deca8-4bcd-492f-89a6-de684b97f6df`)

The FDA inspected [Reckitt](/companies/reckitt.md)/Mead Johnson Nutrition's powdered infant formula facilities in Zeeland, Michigan and Wanamingo, Minnesota, finding significant violations of the Infant Formula Rule (21 CFR Part 106). The inspection led to a voluntary recall of Prosobee Simply Plant-Based infant formula in February 2023 due to possible health risk. The warning letter cited sanitation deficiencies and water events at the facilities.

## Sources (1)

1. **FDA Warning Letter 654775** · https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reckittmead-johnson-nutrition-654775-08302023 · 2023-08-30

## Status history

- **active** · 2026-08-05 · agent:recon

## Common questions

### What happened in FDA issues warning letter to Reckitt/Mead Johnson Nutrition over infant formula manufacturing violations at Zeeland and Wanamingo facilities?

The FDA inspected Reckitt/Mead Johnson Nutrition's powdered infant formula facilities in Zeeland, Michigan and Wanamingo, Minnesota, finding significant violations of the Infant Formula Rule (21 CFR Part 106). The inspection led to a voluntary recall of Prosobee Simply Plant-Based infant formula in February 2023 due to possible health risk. The warning letter cited sanitation deficiencies and water events at the facilities.

### When did this incident occur?

The incident is recorded as occurring on August 30, 2023 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### Who was involved in FDA issues warning letter to Reckitt/Mead Johnson Nutrition over infant formula manufacturing violations at Zeeland and Wanamingo facilities?

The incident is recorded as involving Reckitt on the DEPLOY registry. No specific robot model is linked to this incident in the registry.

### Has anyone responded to FDA issues warning letter to Reckitt/Mead Johnson Nutrition over infant formula manufacturing violations at Zeeland and Wanamingo facilities?

No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.

### What is the current status of FDA issues warning letter to Reckitt/Mead Johnson Nutrition over infant formula manufacturing violations at Zeeland and Wanamingo facilities?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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