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DONGWOODANG PHARMACY CO., LTD. (Yeongcheon Plant)

⚠️ High Risk

FEI: 3011990663 • Yeongcheon-Si, Gyeongsangbugdo • SOUTH KOREA

FEI

FEI Number

3011990663

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Location

Yeongcheon-Si, Gyeongsangbugdo

🇰🇷
🏢

Address

1041-12, Hyo-Ri, Imgo-Myeon, , Yeongcheon-Si, Gyeongsangbugdo, South Korea

High Risk

FDA Import Risk Assessment

52.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

10
Total Refusals
6
Unique Violations
6/22/2006
Latest Refusal
4/20/2005
Earliest Refusal

Score Breakdown

Violation Severity
81.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
85.3×10%
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

21204×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

24602×

UNSFDIETLB

The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.

22001×

DIET INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.

2511×

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:

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

3101×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

Refusal History

DateProductViolationsDivision
6/22/2006
54FYY55PLANTAIN (E.G., WEED), (HERBAL & BOTANICALS, NOT TEAS)
2200DIET INGRE
Los Angeles District Office (LOS-DO)
6/22/2006
54FYY55PLANTAIN (E.G., WEED), (HERBAL & BOTANICALS, NOT TEAS)
2120UNSFDIETSP
Los Angeles District Office (LOS-DO)
6/22/2006
54FYY55PLANTAIN (E.G., WEED), (HERBAL & BOTANICALS, NOT TEAS)
260FALSE
Los Angeles District Office (LOS-DO)
4/20/2005
54ECT99HERBALS & BOTANICAL TEAS, N.E.C.
2460UNSFDIETLB
Los Angeles District Office (LOS-DO)
4/20/2005
54ECT99HERBALS & BOTANICAL TEAS, N.E.C.
2460UNSFDIETLB
Los Angeles District Office (LOS-DO)
4/20/2005
54ECT99HERBALS & BOTANICAL TEAS, N.E.C.
2120UNSFDIETSP
Los Angeles District Office (LOS-DO)
4/20/2005
54ECT99HERBALS & BOTANICAL TEAS, N.E.C.
2120UNSFDIETSP
Los Angeles District Office (LOS-DO)
4/20/2005
54ECT99HERBALS & BOTANICAL TEAS, N.E.C.
2120UNSFDIETSP
Los Angeles District Office (LOS-DO)
4/20/2005
54ECT99HERBALS & BOTANICAL TEAS, N.E.C.
310POISONOUS
Los Angeles District Office (LOS-DO)
4/20/2005
54ECT99HERBALS & BOTANICAL TEAS, N.E.C.
251POISONOUS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is DONGWOODANG PHARMACY CO., LTD. (Yeongcheon Plant)'s FDA import refusal history?

DONGWOODANG PHARMACY CO., LTD. (Yeongcheon Plant) (FEI: 3011990663) has 10 FDA import refusal record(s) in our database, spanning from 4/20/2005 to 6/22/2006.

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. DONGWOODANG PHARMACY CO., LTD. (Yeongcheon Plant)'s FEI number is 3011990663.

What types of violations has DONGWOODANG PHARMACY CO., LTD. (Yeongcheon Plant) received?

DONGWOODANG PHARMACY CO., LTD. (Yeongcheon Plant) has been cited for 6 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 DONGWOODANG PHARMACY CO., LTD. (Yeongcheon Plant) come from?

All FDA import refusal data for DONGWOODANG PHARMACY CO., LTD. (Yeongcheon Plant) 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.