Drug factory · FDA FEI 3002674295
Ropack Inc
10801 Mirabeau St, Montreal, Canada
No problems found at FDA's last inspection, Jun 17, 2022.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2008: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Betaine | Makes it | Orphan Europe SARL | 52276-401 |
| Doxepin | Packages it | Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | 44183-103, 44183-106 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 17, 2022 | No problems found | Drug Quality Assurance | — |
| May 31, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 21, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Jul 29, 2013 | No problems found | Drug Quality Assurance | — |
| Dec 8, 2011 | No problems found | Drug Quality Assurance | — |
| Oct 21, 2008 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 21, 2016 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Lack of or inadequate procedures 21 CFR 820.100(a)
Procedures for corrective and preventive action have not been adequately established. - Training - Lack of or inadequate procedures 21 CFR 820.25(b)
Procedures for training and identifying training needs have not been adequately established. - Equipment suitability & capability 21 CFR 820.72(a)
Certain inspection equipment is not suitable for its intended purposes. - Lack of or inadequate process validation 21 CFR 820.75(a)
A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures.
Registered with FDA for: label; manufacture; pack; relabel; repack.