Drug factory · FDA FEI 2000033505
Zhejiang Jingxin Pharmaceutical Co., Ltd.
No.800, Xinchang Ave. East Rd., Yulin St., Xinchang County, Shaoxing, China
Problems found, fixed voluntarily at FDA's last inspection, Oct 17, 2025.
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 2025: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amitriptyline | Makes it | AiPing Pharmaceutical, Inc. | 11788-077, 11788-078, 11788-079 +3 |
| Cyclobenzaprine | Makes it | AiPing Pharmaceutical, Inc. | 11788-093, 11788-094, 11788-095 |
| Losartan | Makes it | AiPing Pharmaceutical, Inc. | 11788-100, 11788-101, 11788-102 |
| Rosuvastatin | Makes it | AiPing Pharmaceutical, Inc. | 11788-130, 11788-131, 11788-132 +1 |
| Sevelamer | Makes it and tests it | Hangzhou Anprime Biopharm Co., Ltd. | 72823-301, 72823-302 |
| Ticagrelor | Makes it | AiPing Pharmaceutical, Inc. | 11788-157, 11788-158 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 17, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 17, 2025 inspection
- Microbiological testing 21 CFR 211.165(b)
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. - Identity Testing of Each Component 21 CFR 211.84(d)(1)
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
Registered with FDA for: analysis; manufacture; pack.