Drug factory · FDA FEI 3006376135
Nippon Sanso Matheson, Inc.
5555 District Blvd, Vernon, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 11, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2013: 1 with no problems, 2 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 |
|---|---|---|---|
| Mar 11, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 30, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 10, 2013 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 30, 2014 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not established and followed 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.