Drug factory · FDA FEI 3009675181
Nippon Sanso Matheson, Inc.
10540 SW Tualatin Sherwood Rd, Tualatin, OR, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 4, 2015.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2015: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| 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 +19 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 4, 2015 | 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.
Mar 4, 2015 inspection
- 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.
Registered with FDA for: manufacture.