Drug factory · FDA FEI 3008538640
Nippon Kayaku Pharmatech Co., Ltd.
750, Fuchumachiitakura, Toyama, Japan
Problems found, fixed voluntarily at FDA's last inspection, Nov 25, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2022: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Viltolarsen | Makes it | NS Pharma, Inc. | 73292-011 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 25, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Nov 25, 2022 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. - Active ingredient retained sample kept 21 CFR 211.170(a)
A sample which is representative of each lot in each shipment of each active ingredient is not retained. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.