SmithKline Beecham Mexico SA de CV
⚠️ Moderate Risk
FEI: 3004113686 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3004113686
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Avenida Miguel Angel De Quevedo No 307, Col. Romero De Terreros, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, 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
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
Frequently Asked Questions
What is SmithKline Beecham Mexico SA de CV's FDA import refusal history?
SmithKline Beecham Mexico SA de CV (FEI: 3004113686) has 1 FDA import refusal record(s) in our database, spanning from 10/22/2002 to 10/22/2002.
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. SmithKline Beecham Mexico SA de CV's FEI number is 3004113686.
What types of violations has SmithKline Beecham Mexico SA de CV received?
SmithKline Beecham Mexico SA 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 SmithKline Beecham Mexico SA de CV come from?
All FDA import refusal data for SmithKline Beecham Mexico SA 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.