Drug factory · FDA FEI 3012103599
American Welding & Gas, Inc.
113 N SHORECREST RD, Columbia, SC, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 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 |
|---|---|---|---|
| Nitrogen | Makes it | American Welding & Gas, Inc. | 44076-006 |
| Oxygen | Makes it | American Welding & Gas, Inc. | 44076-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 11, 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.
Jul 11, 2019 inspection
- Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
Registered with FDA for: manufacture.