Drug factory · FDA FEI 2221310
A G L Welding Supply Co Inc
600 US Highway 46, Clifton, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 26, 2017.
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 2017: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbon Dioxide | Makes it | AGL Welding Supply Co., Inc. | 17575-104 |
| Helium | Makes it | AGL Welding Supply Co., Inc. | 17575-005 |
| Nitrogen | Makes it | AGL Welding Supply Co., Inc. | 17575-006 |
| Nitrous Oxide | Makes it | AGL Welding Supply Co., Inc. | 17575-011 |
| Oxygen | Makes it | AGL Welding Supply Co., Inc. | 17575-001, 17575-020, 17575-038 +2 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 26, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 26, 2017 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. - Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not established and followed. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. - Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
Registered with FDA for: manufacture.