Drug factory · FDA FEI 3003663281
Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.
No. 288 Jinqu Road, Jinhua, China
Problems found, fixed voluntarily at FDA's last inspection, Apr 28, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2013: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetylcysteine | Makes it | Cameron Pharmaceuticals | 42494-435, 42494-436 |
| Entecavir | Makes it | Cameron Pharmaceuticals | 42494-457, 42494-458 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 13, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 26, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 30, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 23, 2013 | 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.
Apr 28, 2025 inspection
- Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: api manufacture; manufacture.