Dong Wha Pharm Co., Ltd.
⚠️ Moderate Risk
FEI: 3000280808 • Seoul • SOUTH KOREA
FEI Number
3000280808
Location
Seoul
Country
SOUTH KOREAAddress
19/F, 98 Huam-ro, Jung-gu, , Seoul, , South Korea
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 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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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.
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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).
TRANSFAT
The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/11/2016 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/16/2012 | 29CCT99NONALCOHOLIC BEVERAGES, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/19/2005 | 29ACE99NONCARBONATED SOFT DRINK, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/7/2005 | 31KCY99TEA, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/7/2005 | 25GCN99MIXED VEGETABLES, JUICE OR DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/7/2005 | 29YCE99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Dong Wha Pharm Co., Ltd.'s FDA import refusal history?
Dong Wha Pharm Co., Ltd. (FEI: 3000280808) has 6 FDA import refusal record(s) in our database, spanning from 2/7/2005 to 8/11/2016.
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. Dong Wha Pharm Co., Ltd.'s FEI number is 3000280808.
What types of violations has Dong Wha Pharm Co., Ltd. received?
Dong Wha Pharm Co., Ltd. has been cited for 11 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 Dong Wha Pharm Co., Ltd. come from?
All FDA import refusal data for Dong Wha Pharm 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.