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Selder S.A. de C.V.

⚠️ Moderate Risk

FEI: 3001362772 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3001362772

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Calle Fernando M. Villalpando # 48, Col. Guadalupe Inn, Alvaro Obregon, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

36.2
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/9/2012
Latest Refusal
1/28/2010
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
8.8×10%
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

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
5/9/2012
66VDC99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Southwest Import District Office (SWI-DO)
1/28/2010
66VDC99MISCELLANEOUS PATENT MEDICINES, ETC.
178COL ADDED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Selder S.A. de C.V.'s FDA import refusal history?

Selder S.A. de C.V. (FEI: 3001362772) has 2 FDA import refusal record(s) in our database, spanning from 1/28/2010 to 5/9/2012.

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. Selder S.A. de C.V.'s FEI number is 3001362772.

What types of violations has Selder S.A. de C.V. received?

Selder S.A. de C.V. 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 Selder S.A. de C.V. come from?

All FDA import refusal data for Selder 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.