Drug factory · FDA FEI 1616424
Nippon Sanso Matheson, Inc.
4608 US Highway 271, Tyler, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 10, 2015.
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 2015: 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 |
|---|---|---|---|
| Dec 10, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
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 10, 2015 inspection
- Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
The batch production and control records are deficient in that they do not include copy of labeling. - Written sanitation procedures not followed 21 CFR 211.56(b)
Written procedures for sanitation are not followed.
Registered with FDA for: manufacture.