Laboratorios KEM, S de RL de CV
⚠️ High Risk
FEI: 3007602386 • Tijuana, Baja California • MEXICO
FEI Number
3007602386
Location
Tijuana, Baja California
Country
MEXICOAddress
Calle Oslo Y Madrid 3526, Col. Playas De Tijuana Secc Costa Azul, Tijuana, Tijuana, Baja California, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/23/2023 | 54BCY13ZINC (MINERAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/18/2023 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/11/2023 | 54CCY08L-GLUTAMINE (PROTEIN) | Division of Southeast Imports (DSEI) | |
| 7/11/2023 | 54CCY08L-GLUTAMINE (PROTEIN) | Division of Southeast Imports (DSEI) | |
| 7/11/2023 | 54CCY08L-GLUTAMINE (PROTEIN) | Division of Southeast Imports (DSEI) | |
| 7/11/2023 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/16/2018 | 54ACA99VITAMIN, N.E.C. | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 9/1/2015 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 8/27/2015 | 54Y05LAETRILE (APRICOT PITS), VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL,N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/21/2015 | 60LCA65SALSALATE (ANALGESIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/21/2015 | 54YGH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/25/2013 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/26/2013 | 62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/26/2013 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/26/2013 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/26/2013 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/13/2013 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/29/2012 | 54YFF05LAETRILE (APRICOT PITS), VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL,N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/11/2012 | 54YGH05LAETRILE (APRICOT PITS), VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL,N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/23/2011 | 60LCA65SALSALATE (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Laboratorios KEM, S de RL de CV's FDA import refusal history?
Laboratorios KEM, S de RL de CV (FEI: 3007602386) has 20 FDA import refusal record(s) in our database, spanning from 2/23/2011 to 10/23/2023.
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. Laboratorios KEM, S de RL de CV's FEI number is 3007602386.
What types of violations has Laboratorios KEM, S de RL de CV received?
Laboratorios KEM, S de RL de CV has been cited for 5 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 Laboratorios KEM, S de RL de CV come from?
All FDA import refusal data for Laboratorios KEM, S de RL de CV 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.