Drug factory · FDA FEI 3015172373
American Welding & Gas, Inc.
2450 SHADER RD, Orlando, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 22, 2010.
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 2010: 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, 44076-107 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 22, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 22, 2010 inspection
- Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.