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Lemery Sa De Cv

⚠️ Moderate Risk

FEI: 3004758216 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3004758216

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Calle Martires De Rio Blanco 54, Col. Pblo. Stgo.Tepalcatlalpan, U. H. Rinconada Del Sur, Xochimilco, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

37.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/9/2007
Latest Refusal
3/24/2006
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
15.5×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

752×

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).

1181×

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).

Refusal History

DateProductViolationsDivision
7/9/2007
62JCC09LEVODOPA (ANTI-PARKINSONIAN)
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/24/2006
62IIR80GEMCITABINE HCL (ANTI-NEOPLASTIC)
118NOT LISTED
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Lemery Sa De Cv's FDA import refusal history?

Lemery Sa De Cv (FEI: 3004758216) has 2 FDA import refusal record(s) in our database, spanning from 3/24/2006 to 7/9/2007.

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. Lemery Sa De Cv's FEI number is 3004758216.

What types of violations has Lemery Sa De Cv received?

Lemery Sa De Cv 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 Lemery Sa De Cv come from?

All FDA import refusal data for Lemery 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.