Kenvue Canada Inc. — FDA Facility Profile
Kenvue Canada Inc. is an FDA-registered facility (FEI 1000328785) located in Guelph, CA. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 15, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 15, 2025 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) input/output verification (21 CFR 211.68(b)) Absence of Written Procedures (21 CFR 211.100(a)) Valid stability test methods (21 CFR 211.166(a)(3)) and 1 more |
| Dec 1, 2017 | No Action Indicated (NAI) | No citations listed |
| Jul 23, 2010 | Voluntary Action Indicated (VAI) | Written procedures not established/followed (21 CFR 211.67(b)) Procedures to be written and followed (21 CFR 211.198(a)) |
Facility details
- Company
- Kenvue Canada Inc.
- Location
- Guelph (CA)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK
- Source
- decrs