Drug factory · FDA FEI 3003596633
Nippon Sanso Matheson, Inc.
5240 Valley View Ln, Irving, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 17, 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 | Nippon Sanso Matheson, Inc. | 55037-113 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 17, 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.
Apr 17, 2014 inspection
- Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
Registered with FDA for: manufacture.