Kem S.A. Laboratorios
⚠️ Moderate Risk
FEI: 3001431687 • Tijuana • MEXICO
FEI Number
3001431687
Location
Tijuana
Country
MEXICOAddress
Paseo De Tijuana Numero 19 Playas De, , Tijuana, , 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2002 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | Southwest Import District Office (SWI-DO) |
| 12/18/2002 | 54GBH04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/12/2002 | 66VBE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Kem S.A. Laboratorios's FDA import refusal history?
Kem S.A. Laboratorios (FEI: 3001431687) has 3 FDA import refusal record(s) in our database, spanning from 9/12/2002 to 12/18/2002.
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. Kem S.A. Laboratorios's FEI number is 3001431687.
What types of violations has Kem S.A. Laboratorios received?
Kem S.A. Laboratorios has been cited for 2 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 Kem S.A. Laboratorios come from?
All FDA import refusal data for Kem S.A. Laboratorios 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.