Suzhou Huading Body-Building Equipment Co.,
⚠️ Moderate Risk
FEI: 3009774784 • Jiang City • CHINA
FEI Number
3009774784
Location
Jiang City
Country
CHINAAddress
Pu-Pei Industries Development, , Jiang City, , 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
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).
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.
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.
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).
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/18/2012 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Seattle District Office (SEA-DO) | |
| 10/18/2012 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Seattle District Office (SEA-DO) | |
| 10/18/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 10/18/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Suzhou Huading Body-Building Equipment Co.,'s FDA import refusal history?
Suzhou Huading Body-Building Equipment Co., (FEI: 3009774784) has 4 FDA import refusal record(s) in our database, spanning from 10/18/2012 to 10/18/2012.
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. Suzhou Huading Body-Building Equipment Co.,'s FEI number is 3009774784.
What types of violations has Suzhou Huading Body-Building Equipment Co., received?
Suzhou Huading Body-Building Equipment Co., 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 Suzhou Huading Body-Building Equipment Co., come from?
All FDA import refusal data for Suzhou Huading Body-Building Equipment Co., 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.