Drug factory · FDA FEI 3002806779
Daito Pharmaceutical Co., Ltd
326 Yokamachi, Toyama-City, Japan
Problems found, fixed voluntarily at FDA's last inspection, Dec 19, 2023.
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 2011: 0 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Metformin and Pioglitazone | Makes it and tests it | Takeda Pharmaceuticals America, Inc. | 64764-158 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 19, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 16, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 31, 2020 | Serious problems, FDA action | Drug Quality Assurance | — |
| Sep 29, 2011 | 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.
Dec 19, 2023 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - 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.
Registered with FDA for: analysis; api manufacture; manufacture.