Drug factory · FDA FEI 3005947308
Airtec Gases, LLC
2900 S. Highland Ste 19A, Las Vegas, NV, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 30, 2018.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2018: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Airtec Gases, LLC | 24312-002 |
| Nitrous Oxide | Makes it | Airtec Gases, LLC | 24312-003 |
| Oxygen | Makes it | Airtec Gases, LLC | 24312-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 30, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
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 30, 2018 inspection
- Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.