Pun Chun Sauce & Preserved Fruit
⚠️ Moderate Risk
FEI: 11339 • Yuen Long, New Territories • HONG KONG
FEI Number
11339
Location
Yuen Long, New Territories
Country
HONG KONGAddress
Lot No.3927a, In D.D.124; Taan Kwai Tsuen, Yuen Long, New Territories, Hong Kong
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/10/2015 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/10/2015 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/27/2014 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/27/2014 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/27/2014 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Pun Chun Sauce & Preserved Fruit's FDA import refusal history?
Pun Chun Sauce & Preserved Fruit (FEI: 11339) has 5 FDA import refusal record(s) in our database, spanning from 10/27/2014 to 9/10/2015.
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. Pun Chun Sauce & Preserved Fruit's FEI number is 11339.
What types of violations has Pun Chun Sauce & Preserved Fruit received?
Pun Chun Sauce & Preserved Fruit has been cited for 3 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 Pun Chun Sauce & Preserved Fruit come from?
All FDA import refusal data for Pun Chun Sauce & Preserved Fruit 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.