Drug factory · FDA FEI 1950212
Nippon Sanso Matheson, Inc.
9920 Deer Park Rd, Waverly, NE, United States
No problems found at FDA's last inspection, Sep 7, 2023.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2013: 2 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Air | Makes it | Nippon Sanso Matheson, Inc. | 55037-302 |
| Carbon Dioxide | Makes it | Nippon Sanso Matheson, Inc. | 55037-402 |
| Helium | Makes it | Nippon Sanso Matheson, Inc. | 55037-501 |
| Nitrogen | Makes it | Nippon Sanso Matheson, Inc. | 55037-201 |
| Nitrous Oxide | Makes it | Nippon Sanso Matheson, Inc. | 55037-301 |
| Oxygen | Makes it | Nippon Sanso Matheson, Inc. | 55037-113, 55037-602, 55037-612 +18 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 7, 2023 | No problems found | Drug Quality Assurance | — |
| Jun 27, 2013 | 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.
Jun 27, 2013 inspection
- Documentation 21 CFR 820.100(b)
Corrective and preventive action activities and/or results have not been documented. - DHR content 21 CFR 820.184
The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
Registered with FDA for: manufacture.