Drug factory · FDA FEI 3010166685
Oishi Koseido Co., Ltd.
2539-1 Yamaura-Machi, Tosu, Japan
Problems found, fixed voluntarily at FDA's last inspection, Sep 1, 2023.
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 2016: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lidocaine | Makes it, tests it, packages it and labels it | Scilex Pharmaceuticals Inc. | 69557-111 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 1, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Dec 8, 2017 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2016 | Problems found, fixed voluntarily | 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.
Sep 1, 2023 inspection
- Changes to Procedures Not Reviewed, Approved 21 CFR 211.100(a)
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit. - Sampling/testing of labeling/packaging materials 21 CFR 211.122(a)
Labeling and packaging materials are not representatively sampled upon receipt and before use in packaging and labeling of a drug product. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products. - Annual visual exams of drug products 21 CFR 211.170(b)
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. - Written records kept in individual logs 21 CFR 211.182
Written records of major equipment maintenance are not included in individual equipment logs. - input/output verification 21 CFR 211.68(b)
Input to and output from the computer and records or data are not checked for accuracy.
Registered with FDA for: analysis; label; manufacture; pack.