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Church & Dwight,S. De R.L. De C.V.

⚠️ Moderate Risk

FEI: 3006476274 • D.F. • MEXICO

FEI

FEI Number

3006476274

📍

Location

D.F.

🇲🇽

Country

MEXICO
🏢

Address

Av.Jaime Balmesn.8-6 Piso,Off.603 Y 604, , Col.Los Morales Polanco.Mx, D.F., , Mexico

Moderate Risk

FDA Import Risk Assessment

46.5
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
4/23/2012
Latest Refusal
11/1/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
27.1×10%
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

754×

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).

Refusal History

DateProductViolationsDivision
4/23/2012
65FBK99WATER N.E.C. (PHARMACEUTIC AID)
75UNAPPROVED
San Juan District Office (SJN-DO)
11/8/2010
80NIHDISINFECTANT, SUBSYSTEM, WATER PURIFICATION
75UNAPPROVED
San Juan District Office (SJN-DO)
11/1/2010
65FCK99WATER N.E.C. (PHARMACEUTIC AID)
75UNAPPROVED
San Juan District Office (SJN-DO)
11/1/2010
65FCK99WATER N.E.C. (PHARMACEUTIC AID)
75UNAPPROVED
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Church & Dwight,S. De R.L. De C.V.'s FDA import refusal history?

Church & Dwight,S. De R.L. De C.V. (FEI: 3006476274) has 4 FDA import refusal record(s) in our database, spanning from 11/1/2010 to 4/23/2012.

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. Church & Dwight,S. De R.L. De C.V.'s FEI number is 3006476274.

What types of violations has Church & Dwight,S. De R.L. De C.V. received?

Church & Dwight,S. De R.L. De C.V. has been cited for 1 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 Church & Dwight,S. De R.L. De C.V. come from?

All FDA import refusal data for Church & Dwight,S. De R.L. 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.