Drug factory · FDA FEI 3002807376
KAKEN Pharmaceutical Co., LTD
301 Gensuke, Fujieda-shi, Japan
No problems found at FDA's last inspection, Sep 1, 2023.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2012: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Efinaconazole | Makes it | Bausch Health US, LLC | 0187-5400 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 1, 2023 | No problems found | Drug Quality Assurance | — |
| Jun 22, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
| Mar 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 14, 2012 | 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.
Jun 22, 2018 inspection
- 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. - Theoretical yield statement including percentages 21 CFR 211.186(b)(7)
Master production and control records lack a statement of theoretical yield including the maximum and minimum percentages of theoretical yield beyond which investigation is required. - Identification of Equipment and Lines 21 CFR 211.188(b)(2)
The batch production and control records are deficient in that they do not include the identity of major equipment used. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Backup file not maintained 21 CFR 211.68(b)
Failure to maintain a backup file of data entered into the computer or related system. - input/output verification 21 CFR 211.68(b)
Input to and output from the computer, related systems of formulas and records or data are not checked for accuracy. - Top/Middle/Bottom container sampling 21 CFR 211.84(c)(4)
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.