Drug factory · FDA FEI 1000151065
Oxarc, LLC
3530 N Ramsey Rd, Coeur D Alene, ID, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 23, 2019.
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 2019: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Air | Makes it | Oxarc, LLC | 34057-006 |
| Nitrogen | Makes it | Oxarc, LLC | 34057-014 |
| Nitrous Oxide | Makes it | Oxarc, LLC | 34057-010 |
| Oxygen | Makes it | Oxarc, LLC | 34057-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 23, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
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 23, 2019 inspection
- GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration and inspection of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.