Drug factory · FDA FEI 3007349281
Roberts Oxygen Company, Inc.
4100 Chesapeake Drive, Charlotte, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 10, 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 |
|---|---|---|---|
| Carbon Dioxide | Makes it | Roberts Oxygen Company, Inc. | 46123-050, 46123-240 |
| Carbon Dioxide and Oxygen | Makes it | Roberts Oxygen Company, Inc. | 46123-115, 46123-117, 46123-120 +15 |
| Nitrogen | Makes it | Roberts Oxygen Company, Inc. | 46123-003, 46123-004 |
| Oxygen | Makes it | Roberts Oxygen Company, Inc. | 46123-001, 46123-002, 46123-109 +7 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 10, 2019 | 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 10, 2019 inspection
- Labeling control records including specimens or copies 21 CFR 211.188(b)(8)
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
Registered with FDA for: manufacture.