Company
CanadaRopack, Inc. (Site A & B), Anjou, Canada – FDA Inspections
Inspection records and compliance data for Ropack, Inc. (Site A & B) in Anjou. 9 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 17, 2022.
Company Profile
This profile covers Ropack, Inc. (Site A & B) based in Anjou, Canada.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 1
- VAI
- 2
- NAI
- 6
- Form 483s
- 1
- Warning letters
- 0
First inspected October 21, 2008. Last inspected June 17, 2022.
Most cited issue areas
- Control procedures to monitor and validate performance1 inspection
- Equipment suitability & capability1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 17, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1173334 |
| May 31, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1060715 |
| July 20, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1027604 |
| January 21, 2016 | OAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 957414 |
| July 29, 2013 | NAI | Human Drugs · Drug Quality Assurance | 844391 |
| December 8, 2011 | NAI | Human Drugs · Drug Quality Assurance | 762148 |
| September 1, 2011 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 744374 |
| August 30, 2011 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 744373 |
| October 21, 2008 | VAI | Human Drugs · Drug Quality Assurance | 545831 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Ropack, Inc. (Site A & B)
FEI Number
3002674295
Address
10801 Mirabeau St, Anjou, Canada
Country
Canada
ID: 31a3b387-891e-4940-9bdd-056099d390eb