Drug factory · FDA FEI 3014772595
Shenzhen Hepalink Pharmaceutical Group Co., Ltd.
No. 1 Rongtian Road, Kengzi Sub-district, Pingshan District, Shenzhen, China
Problems found, fixed voluntarily at FDA's last inspection, Jun 13, 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 |
|---|---|---|---|
| Heparin | Makes the active ingredient | Hepalink USA Inc., McKesson Packaging Services Business Unit of McKesson Corporation, Northstar Rx LLC., Sandoz Inc. | 81952-111, 81952-112, 81952-113 +24 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 13, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.