Shandong Haiyan Medical Manufacture Co., Ltd.
⚠️ High Risk
FEI: 3009525820 • Xintai, Shandong • CHINA
FEI Number
3009525820
Location
Xintai, Shandong
Country
CHINAAddress
No. 1 Haiyan Road, , Xintai, Shandong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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 |
|---|---|---|---|
| 10/26/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/26/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/26/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/26/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/13/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/4/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/4/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/20/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/20/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/19/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/1/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/1/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/18/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/17/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/4/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/6/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 6/6/2023 | 62FAY23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shandong Haiyan Medical Manufacture Co., Ltd.'s FDA import refusal history?
Shandong Haiyan Medical Manufacture Co., Ltd. (FEI: 3009525820) has 17 FDA import refusal record(s) in our database, spanning from 6/6/2023 to 10/26/2023.
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. Shandong Haiyan Medical Manufacture Co., Ltd.'s FEI number is 3009525820.
What types of violations has Shandong Haiyan Medical Manufacture Co., Ltd. received?
Shandong Haiyan Medical Manufacture Co., Ltd. has been cited for 2 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 Shandong Haiyan Medical Manufacture Co., Ltd. come from?
All FDA import refusal data for Shandong Haiyan Medical Manufacture 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.