Insect Biotech Co., Ltd
⚠️ Moderate Risk
FEI: 3005395140 • Daejeon • SOUTH KOREA
FEI Number
3005395140
Location
Daejeon
Country
SOUTH KOREAAddress
461-7 Jeonmin Yuseong, , Daejeon, , 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
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).
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.
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 FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LACKS FIRM
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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/14/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 1/14/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 1/14/2010 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 1/14/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/14/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 1/14/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/14/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Insect Biotech Co., Ltd's FDA import refusal history?
Insect Biotech Co., Ltd (FEI: 3005395140) has 7 FDA import refusal record(s) in our database, spanning from 1/14/2010 to 1/14/2010.
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. Insect Biotech Co., Ltd's FEI number is 3005395140.
What types of violations has Insect Biotech Co., Ltd received?
Insect Biotech Co., Ltd has been cited for 8 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 Insect Biotech Co., Ltd come from?
All FDA import refusal data for Insect Biotech 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.