FDA issues warning letter to Reckitt/Mead Johnson Nutrition over infant formula manufacturing violations at Zeeland and Wanamingo facilities
[REGULATORY ACTION]Aug 30, 2023 · Investigated by FDA · Reckitt
Failure Mode
REGULATORY ACTION
Event Date
Aug 30, 2023
Primary Entity
Investigated by FDA
Robotic Platform
Reckitt
Jurisdiction / Location
Federal / Global
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reckittmead-johnson-nutrition-654775-08302023
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reckittmead-johnson-nutrition-654775-08302023
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Details
Incident Context & FAQ
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.