Drug factory · FDA FEI 1513845
Delille Oxygen Company
772 Marion Rd, Columbus, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 12, 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 |
|---|---|---|---|
| Nitrogen | Makes it | Delille Oxygen Company | 10304-601 |
| Oxygen | Makes it | Delille Oxygen Company | 10304-463 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 12, 2017 | 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.
Apr 12, 2017 inspection
- Quarantine of Rejected Components et. al. 21 CFR 211.89
Rejected drug product containers are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
Registered with FDA for: manufacture.