Drug factory · FDA FEI 1000138346
Helget Gas Products, Inc.
4150 S 87th St, Omaha, NE, United States
No problems found at FDA's last inspection, Jul 29, 2025.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 5 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 | 52086-012 |
| Nitrous Oxide | Makes it | Helget Gas Products | 52086-015 |
| Oxygen | Makes it | Helget Gas Products | 52086-011, 52086-020 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 29, 2025 | No problems found | Drug Quality Assurance | — |
| Jun 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Apr 22, 2015 | No problems found | Drug Quality Assurance | — |
| Dec 12, 2011 | No problems found | Drug Quality Assurance | — |
| Nov 4, 2010 | No problems found | Drug Quality Assurance | — |
| Oct 1, 2009 | 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.
Jun 7, 2017 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Testing and standardization of standards et. al. 21 CFR 211.194(c)
Laboratory records do not include complete records of any testing and standardization of laboratory reference standards. - Adequate space lacking to prevent mix-ups and contamination 21 CFR 211.42(b)
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between drug products and to prevent contamination.
Registered with FDA for: manufacture.