Drug factory · FDA FEI 1642874
Nippon Sanso Matheson, Inc.
2121 E Interstate 20, Odessa, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 24, 2014.
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 2014: 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 |
| Oxygen | Makes it | Clovis Equipment & Supply Company | 53730-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 24, 2014 | 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.
Jul 24, 2014 inspection
- Records reviewed annually 21 CFR 211.180(e)
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
Registered with FDA for: manufacture.