Drug factory · FDA FEI 3000215307
American Welding & Gas, Inc.
15692 Lincoln Hwy, Plymouth, IN, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 27, 2012.
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 2012: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | American Welding & Gas, Inc. | 44076-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 27, 2012 | 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.
Sep 27, 2012 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Sampling and testing plans not followed 21 CFR 211.165(c)
Written procedures for sampling and testing plans are not followed for each drug product.
Registered with FDA for: manufacture.