Drug factory · FDA FEI 2127862
Nippon Sanso Matheson, Inc.
3191 Mike Collins Dr, Eagan, MN, United States
No problems found at FDA's last inspection, Dec 5, 2012.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2010: 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 |
| 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 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 5, 2012 | No problems found | Drug Quality Assurance | 1 |
| Jan 26, 2010 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 5, 2012 inspection
- Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals in accordance with an established written program.
Registered with FDA for: manufacture.