Industrias Quimicas Kemed
⚠️ Moderate Risk
FEI: 3004268316 • Tijuana, BC • MEXICO
FEI Number
3004268316
Location
Tijuana, BC
Country
MEXICOAddress
Callejon de las Moras No.11901, Colonia 20 de Noviembre, Tijuana, BC, Mexico
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).
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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.
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2023 | 54BCY20SELENIUM (MINERAL) | Division of Southeast Imports (DSEI) | |
| 7/11/2023 | 54YCY08COENZYME Q10 (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Division of Southeast Imports (DSEI) | |
| 7/11/2023 | 54ECY84MILK THISTLE | Division of Southeast Imports (DSEI) | |
| 8/1/2011 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 8/1/2011 | 66VCK99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 12/6/2005 | 62GBH99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/5/2005 | 62GBH99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/5/2005 | 63EBH99CARDIAC DEPRESSANT N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Industrias Quimicas Kemed's FDA import refusal history?
Industrias Quimicas Kemed (FEI: 3004268316) has 8 FDA import refusal record(s) in our database, spanning from 12/5/2005 to 7/11/2023.
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. Industrias Quimicas Kemed's FEI number is 3004268316.
What types of violations has Industrias Quimicas Kemed received?
Industrias Quimicas Kemed 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 Industrias Quimicas Kemed come from?
All FDA import refusal data for Industrias Quimicas Kemed 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.