Drug factory · FDA FEI 3000278252
New Bedford Welding Supply, Inc.
286 Herman Melville Blvd Unit 6, New Bedford, MA, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 21, 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 2010: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | New Bedford Welding Supply, Inc. | 23650-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 21, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 14, 2010 | 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.
Dec 21, 2015 inspection
- Expiration date lacking 21 CFR 211.137(a)
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Registered with FDA for: manufacture.