Drug factory · FDA FEI 1034958
Volunteer Welding Supply, Inc.
815 Rep John Lewis Way S, Nashville, TN, United States
No problems found at FDA's last inspection, Jun 15, 2011.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2010: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Volunteer Welding Supply Inc | 53511-004 |
| Oxygen | Makes it | Volunteer Welding Supply Inc | 53511-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 15, 2011 | No problems found | Drug Quality Assurance | — |
| May 21, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 21, 2010 inspection
- Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not reviewed and approved by the quality control unit. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations. - Consultant Records 21 CFR 211.34
Records are not maintained stating the consultant's name, address, qualifications, and type of service provided. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.