Drug factory · FDA FEI 1627208
Nippon Sanso Matheson, Inc.
2040 California Crossing Rd, Dallas, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 9, 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 |
|---|---|---|---|
| Air | Makes it | Nippon Sanso Matheson, Inc. | 55037-302 |
| Carbon Dioxide | Makes it | Nippon Sanso Matheson, Inc. | 55037-402 |
| Nitrogen | Makes it | Nippon Sanso Matheson, Inc. | 55037-201 |
| Nitrous Oxide | Makes it | Nippon Sanso Matheson, Inc. | 55037-301 |
| Oxygen | Makes it | Nippon Sanso Matheson, Inc. | 55037-113, 55037-602, 55037-612 +19 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 9, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 20, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 19, 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.
Dec 9, 2022 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.
Nov 20, 2015 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: manufacture.