Shandong Xinhua Pharmaceutical Co., Ltd. First Plant
⚠️ Moderate Risk
FEI: 3002808153 • Zibo, Shandong • CHINA
FEI Number
3002808153
Location
Zibo, Shandong
Country
CHINAAddress
Zibo High & New Technology, East Chemical Zone Zhangdian District, Zibo, Shandong, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/29/2023 | 62GAS41IBUPROFEN (ANTI-INFLAMMATORY) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/26/2018 | 80FLESTERILIZER, STEAM | Division of Southeast Imports (DSEI) | |
| 9/29/2015 | 60LCZ04ANTIPYRINE (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 9/29/2015 | 60LCZ04ANTIPYRINE (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 10/31/2014 | 60LCT04ANTIPYRINE (ANALGESIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/24/2014 | 64LPR37HYDROCORTISONE (GLUCOCORTICOID) | 72NEW VET DR | Atlanta District Office (ATL-DO) |
| 9/12/2013 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/17/2013 | 60LDS04ANTIPYRINE (ANALGESIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 5/7/2013 | 60LDS04ANTIPYRINE (ANALGESIC) | Division of Northeast Imports (DNEI) | |
| 2/28/2012 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/27/2011 | 62GIZ41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/26/2007 | 61HCS03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/23/2006 | 60LAR05ASPIRIN (ANALGESIC) | New York District Office (NYK-DO) | |
| 3/9/2006 | 64LCS37HYDROCORTISONE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 8/5/2004 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Shandong Xinhua Pharmaceutical Co., Ltd. First Plant's FDA import refusal history?
Shandong Xinhua Pharmaceutical Co., Ltd. First Plant (FEI: 3002808153) has 15 FDA import refusal record(s) in our database, spanning from 8/5/2004 to 6/29/2023.
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 Xinhua Pharmaceutical Co., Ltd. First Plant's FEI number is 3002808153.
What types of violations has Shandong Xinhua Pharmaceutical Co., Ltd. First Plant received?
Shandong Xinhua Pharmaceutical Co., Ltd. First Plant has been cited for 7 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 Xinhua Pharmaceutical Co., Ltd. First Plant come from?
All FDA import refusal data for Shandong Xinhua Pharmaceutical Co., Ltd. First Plant 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.