Zhejiang Shengmei Electroacoustic Materials Co Ltd
✅ Low Risk
FEI: 1000542115 • Zhejiang • CHINA
FEI Number
1000542115
Location
Zhejiang
Country
CHINAAddress
Ziaozhen Shen County, , Zhejiang, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
Refusal History
Frequently Asked Questions
What is Zhejiang Shengmei Electroacoustic Materials Co Ltd's FDA import refusal history?
Zhejiang Shengmei Electroacoustic Materials Co Ltd (FEI: 1000542115) has 2 FDA import refusal record(s) in our database, spanning from 9/16/2002 to 12/18/2015.
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. Zhejiang Shengmei Electroacoustic Materials Co Ltd's FEI number is 1000542115.
What types of violations has Zhejiang Shengmei Electroacoustic Materials Co Ltd received?
Zhejiang Shengmei Electroacoustic Materials Co Ltd has been cited for 4 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 Zhejiang Shengmei Electroacoustic Materials Co Ltd come from?
All FDA import refusal data for Zhejiang Shengmei Electroacoustic Materials 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.