Drug factory · FDA FEI 1919930
Nippon Sanso Matheson, Inc.
1630 NE 54th Ave, Des Moines, IA, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 8, 2011.
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 2011: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Nippon Sanso Matheson, Inc. | 55037-113 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 8, 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.
Sep 8, 2011 inspection
- Examination of packaging and labeling 21 CFR 211.130(d)
Examination of packaging and labeling materials for suitability and correctness before packaging operations is not performed and not documented in the batch production records.
Registered with FDA for: manufacture.