Drug factory · FDA FEI 3003730218
Nippon Sanso Matheson, Inc.
1100 Hensley St, Richmond, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 19, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2010: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrous Oxide | Makes it | Nippon Sanso Matheson, Inc. | 55037-301 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 19, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 27, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 30, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 10, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
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 19, 2019 inspection
- Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Jun 10, 2010 inspection
- Records not made readily available to FDA 21 CFR 211.180(c)
Records associated with drug product components, containers, labeling, production, control, and distribution and within the retention period for such records, were not made readily available for authorized inspection. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Component identification test 21 CFR 211.84(d)(2)
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis. - Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Registered with FDA for: manufacture.