Drug factory · FDA FEI 3019318
Nippon Sanso Matheson, Inc.
3886 NE Steelhead Run Dr, Albany, OR, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 10, 2017.
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 2017: 0 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 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 10, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
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, 2017 inspection
- Accurate reproduction 21 CFR 211.188(a)
The batch production and control records are deficient in that they are not checked for accuracy, dated, and signed. - Supervisor Training/Education/Experience 21 CFR 211.25(b)
Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, packing and holding of a drug product are not maintained in a good state of repair.
Registered with FDA for: manufacture.