Drug factory · FDA FEI 3002808398
Teikoku Seiyaku Co.,ltd.
567, SAMBOMMATSU, Higashikagawa, Japan
No problems found at FDA's last inspection, Feb 14, 2025.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lidocaine | Makes it | Golden State Medical Supply, Inc., Par Health USA, LLC | 51407-827, 0603-1880 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 14, 2025 | No problems found | Drug Quality Assurance | — |
| Jul 6, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Sep 9, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Mar 26, 2009 | 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.
Jul 6, 2018 inspection
- Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Mar 14, 2014 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established. - Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
All records of production associated with a batch of drug product are not maintained at least one (1) year after the expiration date. - Suitability of testing methods verified 21 CFR 211.194(a)(2)
The suitability of all testing methods is not verified under actual conditions of use. - Reason for Not Conducting Complaint Investigation 21 CFR 211.198(b)(3)
Complaint records are deficient in that they do not document the reason and the individual making the decision not to conduct a complaint investigation. - Representative Samples 21 CFR 211.84(b)
Representative samples are not taken of each shipment of each lot of components for testing or examination.
Registered with FDA for: analysis; label; manufacture; pack.