Drug factory · FDA FEI 1000151063
Oxarc, LLC
2256 Elmway, Okanogan, WA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 14, 2017.
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 2017: 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 |
|---|---|---|---|
| Jul 14, 2017 | 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.
Jul 14, 2017 inspection
- Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not followed. - 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. - Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the maintenance of equipment.
Registered with FDA for: manufacture.