Zoetis LLC — FDA Facility Profile
Zoetis LLC is an FDA-registered facility (FEI 3010146372) located in Kalamazoo, MI, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Feb 13, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 6 (3 VAI, 3 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
- 9
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 13, 2024 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Equipment Design, Size and Location (21 CFR 211.63) Absence of Written Procedures (21 CFR 211.100(a)) Floors, walls, ceiling surfaces (21 CFR 211.42(c)(10)(i)) and 3 more |
| May 3, 2021 | Voluntary Action Indicated (VAI) | Authority lacking to review records, investigate errors (21 CFR 211.22(a)) Procedures not in writing, fully followed (21 CFR 211.22(d)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Cleaning System (21 CFR 211.42(c)(10)(v)) and 3 more |
| Apr 11, 2019 | No Action Indicated (NAI) | No citations listed |
| Aug 19, 2016 | No Action Indicated (NAI) | No citations listed |
| Jun 29, 2015 | No Action Indicated (NAI) | No citations listed |
| Apr 17, 2014 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Procedures for sterile drug products (21 CFR 211.113(b)) |
Facility details
- Company
- Zoetis LLC
- Location
- Kalamazoo, MI (US)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; LABEL; MANUFACTURE; PACK; RELABEL; REPACK
- Source
- decrs