JOC GREAT WALL Corp
⚠️ Moderate Risk
FEI: 2000026796 • Nanjing, Jiangsu • CHINA
FEI Number
2000026796
Location
Nanjing, Jiangsu
Country
CHINAAddress
8 Liyuan Rd South, Jiangning Dis, , Nanjing, Jiangsu, 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
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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).
MELAMINE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/2/2013 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | San Francisco District Office (SAN-DO) | |
| 5/2/2013 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | New England District Office (NWE-DO) | |
| 5/2/2013 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | New England District Office (NWE-DO) | |
| 4/10/2009 | 72BGB05COMB PROD PET DOG FOOD | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is JOC GREAT WALL Corp's FDA import refusal history?
JOC GREAT WALL Corp (FEI: 2000026796) has 4 FDA import refusal record(s) in our database, spanning from 4/10/2009 to 7/2/2013.
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. JOC GREAT WALL Corp's FEI number is 2000026796.
What types of violations has JOC GREAT WALL Corp received?
JOC GREAT WALL Corp has been cited for 9 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 JOC GREAT WALL Corp come from?
All FDA import refusal data for JOC GREAT WALL Corp 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.