Drug factory · FDA FEI 1036503
Nexair, LLC
2534 NW 16th Blvd, Okeechobee, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 12, 2024.
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 2024: 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 | NexAir, LLC, Praxair Distribution Southeast LLC | 12213-498, 49972-002 |
| Nitrous Oxide | Makes it | Praxair Distribution Southeast LLC | 49972-004 |
| Oxygen | Makes it | NexAir, LLC, Praxair Distribution Southeast LLC | 12213-720, 49972-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
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 12, 2024 inspection
- 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.
Registered with FDA for: manufacture.