Drug factory · FDA FEI 1000219789
Nippon Sanso Matheson, Inc.
1224 McDonald St, Charleston, WV, United States
No problems found at FDA's last inspection, Aug 18, 2016.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2011: 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 | Nippon Sanso Matheson, Inc. | 55037-201 |
| Oxygen | Makes it | Nippon Sanso Matheson, Inc. | 55037-113 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 18, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 10, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
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 10, 2011 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.
Registered with FDA for: manufacture.