Drug factory · FDA FEI 1000510744
Helget Gas Products, Inc.
2105 ATLANTIC, North Kansas City, MO, United States
No problems found at FDA's last inspection, Oct 30, 2024.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2011: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Helget Gas Products | 52086-002, 52086-012 |
| Nitrous Oxide | Makes it | Helget Gas Products | 52086-015 |
| Oxygen | Makes it and repackages it | Helget Gas Products | 52086-001, 52086-004, 52086-011 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 30, 2024 | No problems found | Drug Quality Assurance | — |
| Jun 23, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 19, 2015 | No problems found | Drug Quality Assurance | — |
| May 3, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 2, 2011 | No problems found | 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.
May 3, 2013 inspection
- Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Registered with FDA for: manufacture.