Drug factory · FDA FEI 3003281037
Arkansas Welding Supply, Inc.
230 Valley St, Hot Springs National Park, AR, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 28, 2015.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2011: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Arkansas Welding Supply, Inc. | 65603-200 |
| Oxygen | Makes it | Arkansas Welding Supply, Inc. | 65603-100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 28, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 8, 2011 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 28, 2015 inspection
- Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the receipt, identification, sampling, testing, approval, and rejection of components. - Components withheld from use pending release 21 CFR 211.84(a)
Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
Registered with FDA for: manufacture.