Drug factory · FDA FEI 1000041224
Metro Welding Supply Corporation
12620 Southfield Fwy, Detroit, MI, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 20, 2011.
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 2011: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Air | Makes it | Metro Welding Supply Corporation | 62273-003 |
| Nitrogen | Makes it | Metro Welding Supply Corporation | 62273-002 |
| Nitrous Oxide | Makes it | Metro Welding Supply Corporation | 62273-005 |
| Oxygen | Makes it | Metro Welding Supply Corporation | 62273-001, 62273-007 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 20, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
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 20, 2011 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.