Hebei Pukang Medical Instruments Co., Ltd.
⚠️ Moderate Risk
FEI: 3007744192 • Baoding, Hebei • CHINA
FEI Number
3007744192
Location
Baoding, Hebei
Country
CHINAAddress
Dongshiduan Town, Xushui County, Baoding, Hebei, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/9/2024 | 80FPOSTRETCHER, WHEELED | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/13/2020 | 73BRYCABINET, TABLE AND TRAY, ANESTHESIA | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/13/2020 | 73BRYCABINET, TABLE AND TRAY, ANESTHESIA | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/13/2020 | 73BRYCABINET, TABLE AND TRAY, ANESTHESIA | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/13/2020 | 73BRYCABINET, TABLE AND TRAY, ANESTHESIA | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/13/2020 | 73BRYCABINET, TABLE AND TRAY, ANESTHESIA | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 8/19/2009 | 80FNKBED, HYDRAULIC, ADJUSTABLE HOSPITAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/10/2008 | 79BWNTABLE AND ATTACHMENTS, OPERATING-ROOM | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/10/2008 | 80FNKBED, HYDRAULIC, ADJUSTABLE HOSPITAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/10/2008 | 80FMSBED, PEDIATRIC OPEN HOSPITAL | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Hebei Pukang Medical Instruments Co., Ltd.'s FDA import refusal history?
Hebei Pukang Medical Instruments Co., Ltd. (FEI: 3007744192) has 10 FDA import refusal record(s) in our database, spanning from 6/10/2008 to 2/9/2024.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Hebei Pukang Medical Instruments Co., Ltd.'s FEI number is 3007744192.
What types of violations has Hebei Pukang Medical Instruments Co., Ltd. received?
Hebei Pukang Medical Instruments Co., Ltd. has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Hebei Pukang Medical Instruments Co., Ltd. come from?
All FDA import refusal data for Hebei Pukang Medical Instruments Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.