Ropack Inc — FDA Facility Profile
Ropack Inc is an FDA-registered facility (FEI 3002674295) located in Montreal, CA. Registered operations: LABEL; MANUFACTURE; PACK; RELABEL; REPACK. RegDataLab tracks 9 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Jun 17, 2022: No Action Indicated (NAI)
- Inspections on record
- 9 (1 OAI, 2 VAI, 6 NAI)
- Last OAI inspection
- Jan 21, 2016
- Warning letters
- 1 listed by FDA for this FEI, latest Aug 3, 2016
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 17, 2022 | No Action Indicated (NAI) | No citations listed |
| May 31, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 20, 2017 | No Action Indicated (NAI) | No citations listed |
| Jan 21, 2016 | Official Action Indicated (OAI) | Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Equipment suitability & capability (21 CFR 820.72(a)) Control procedures to monitor and validate performance (21 CFR 211.110(a)) and 1 more |
| Jul 29, 2013 | No Action Indicated (NAI) | No citations listed |
| Dec 8, 2011 | No Action Indicated (NAI) | No citations listed |
| Sep 1, 2011 | No Action Indicated (NAI) | No citations listed |
| Aug 30, 2011 | No Action Indicated (NAI) | No citations listed |
| Oct 21, 2008 | Voluntary Action Indicated (VAI) | No citations listed |
Facility details
- Company
- Ropack, Inc. (Site A & B)
- Location
- Montreal (CA)
- Registration Expires
- Dec 31, 2026
- Operations
- LABEL; MANUFACTURE; PACK; RELABEL; REPACK
- Source
- decrs