Drug factory · FDA FEI 3003406963
Helget Gas Products, Inc.
1151 N Ellis St, Bensenville, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 5, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2011: 4 with no problems, 3 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 |
|---|---|---|---|
| Aug 5, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 23, 2023 | No problems found | Drug Quality Assurance | — |
| Aug 3, 2017 | No problems found | Drug Quality Assurance | — |
| Jul 7, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 26, 2014 | Problems found, fixed voluntarily | Postmarket Surv. and Epidemiology | 2 |
| Aug 26, 2014 | No problems found | Drug Quality Assurance | 2 |
| Jun 3, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 5, 2025 inspection
- Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Aug 26, 2014 inspection
- Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of post marketing adverse drug experiences. - Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of post marketing adverse drug experiences.
Jun 3, 2011 inspection
- Proper disposal of adulterated product 21 CFR 110.80(b)(9)
Failure to dispose of adulterated in a manner which protects against the contamination of other food. - Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Acceptance criteria for sampling & testing 21 CFR 211.165(d)
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Labeling control records including specimens or copies 21 CFR 211.188(b)(8)
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Adverse Drug Experience 21 CFR 211.198(a)
Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA.
Registered with FDA for: manufacture.