# FDA 483 - CANADA ROYAL MILK ULC - August 15, 2025

Source: https://www.keypedia.com/records/483/canada-royal-milk-ulc/b463841c-5f73-41b3-9157-73553f4d3df9

> FDA 483 for CANADA ROYAL MILK ULC on August 15, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CANADA ROYAL MILK ULC
- Inspection Date: 2025-08-15
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of CANADA ROYAL MILK, an infant formula manufacturer in Kingston, Ontario, revealed significant deficiencies in its process control system. The firm failed to adequately monitor its production environment for microorganisms, leading to positive findings for Cronobacter sakazakii in both product and environmental samples. Additionally, the company's procedures for corrective actions and investigations into contamination events and facility issues like roof leaks were found to be inadequate.

## Related Officers

- [Consumer Safety Officer/Investigator](https://www.keypedia.com/people/bing-lin/7037e34a-15df-4e81-bd35-bd91b9ab167a)
- [Karla J. Gibler](https://www.keypedia.com/people/karla-j-gibler/dec8a20a-9b09-424a-96b5-62b20178995d)

Company: https://www.keypedia.com/companies/canada-royal-milk-ulc/36e7be90-df22-49f1-b674-3497a7e05c6b

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8