Drug factory · FDA FEI 1629795
Temple Industrial Welding Supply Co
Temple, Texas, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
No problems found at FDA's last inspection, Feb 27, 2017.
No Action Indicated: inspectors found no objectionable conditions.
1 drug inspection on record since 2017: 1 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Temple Industrial Welding Supply Co | 11103-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 27, 2017 | No problems found | 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.
Feb 27, 2017 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. - Identification of Each Lot in Each Shipment 21 CFR 211.80(d)
Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for components.