Eli Lilly y Compania De Mexico S.A. de C.V.

⚠️ Moderate Risk

FEI: 3002809486 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3002809486

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO

🏢

Address

Calzada De Tlalpan No. 2024, Col. Ciudad Jardin, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

44.6

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

4/22/2016

Latest Refusal

11/27/2001

Earliest Refusal

Score Breakdown

Violation Severity

77.5×40%

Refusal Volume

42.5×30%

Recency

0.0×20%

Frequency

9.0×10%

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

Violation Summary

726×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

756×

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).

1183×

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).

3421×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

Refusal History

Date	Product	Violations	Division
4/22/2016	61NCA29FLUOXETINE (ANTI-DEPRESSANT)	75UNAPPROVED	New Orleans District Office (NOL-DO)
11/16/2011	61PCP99ANTI-DIABETIC N.E.C.	75UNAPPROVED	New Orleans District Office (NOL-DO)
1/4/2011	64RCY21SOMATROPIN (HORMONE)	342PERSONALRX 75UNAPPROVED	New Orleans District Office (NOL-DO)
8/31/2007	66SCB51TADALAFIL	75UNAPPROVED	New Orleans District Office (NOL-DO)
2/18/2003	64RCK22SOMATROPIN (RDNA ORIGIN) (HORMONE)	118NOT LISTED 75UNAPPROVED	Florida District Office (FLA-DO)
2/18/2003	64RCK22SOMATROPIN (RDNA ORIGIN) (HORMONE)	118NOT LISTED 75UNAPPROVED	Florida District Office (FLA-DO)
3/27/2002	68YAS05SWINE ANIMAL DRUGS N.E.C.	72NEW VET DR	Florida District Office (FLA-DO)
1/18/2002	68YAS05SWINE ANIMAL DRUGS N.E.C.	118NOT LISTED	Florida District Office (FLA-DO)
12/18/2001	68YAS05SWINE ANIMAL DRUGS N.E.C.	72NEW VET DR	Florida District Office (FLA-DO)
11/27/2001	68YAS05SWINE ANIMAL DRUGS N.E.C.	72NEW VET DR	Florida District Office (FLA-DO)
11/27/2001	68YAS05SWINE ANIMAL DRUGS N.E.C.	72NEW VET DR	Florida District Office (FLA-DO)
11/27/2001	68YAS05SWINE ANIMAL DRUGS N.E.C.	72NEW VET DR	Florida District Office (FLA-DO)
11/27/2001	68YAS05SWINE ANIMAL DRUGS N.E.C.	72NEW VET DR	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Eli Lilly y Compania De Mexico S.A. de C.V.'s FDA import refusal history?

Eli Lilly y Compania De Mexico S.A. de C.V. (FEI: 3002809486) has 13 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 4/22/2016.

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. Eli Lilly y Compania De Mexico S.A. de C.V.'s FEI number is 3002809486.

What types of violations has Eli Lilly y Compania De Mexico S.A. de C.V. received?

Eli Lilly y Compania De Mexico S.A. de C.V. has been cited for 4 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 Eli Lilly y Compania De Mexico S.A. de C.V. come from?

All FDA import refusal data for Eli Lilly y Compania De Mexico S.A. de C.V. 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.