Dongguan Yang Shi Food Factory
⚠️ Moderate Risk
FEI: 3003297568 • Guangdong • CHINA
FEI Number
3003297568
Location
Guangdong
Country
CHINAAddress
Guan Long Lu Tian Tia Village, , Guangdong, , 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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/11/2003 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 3/11/2003 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Los Angeles District Office (LOS-DO) | |
| 9/17/2002 | 27YGF06PEPPER SAUCE (HOT, MILD, ETC.) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 9/17/2002 | 34FGF02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Dongguan Yang Shi Food Factory's FDA import refusal history?
Dongguan Yang Shi Food Factory (FEI: 3003297568) has 18 FDA import refusal record(s) in our database, spanning from 9/17/2002 to 3/11/2003.
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. Dongguan Yang Shi Food Factory's FEI number is 3003297568.
What types of violations has Dongguan Yang Shi Food Factory received?
Dongguan Yang Shi Food Factory 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 Dongguan Yang Shi Food Factory come from?
All FDA import refusal data for Dongguan Yang Shi Food Factory 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.