Drug factory · FDA FEI 3001236534
Eugene Welders Supply Co
3500 COMMERCIAL AVE, Springfield, OR, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 17, 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 2011: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | 801576526 | 64169-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 17, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 5, 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.
Mar 17, 2015 inspection
- Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Aug 5, 2011 inspection
- Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not followed. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Registered with FDA for: manufacture.