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INDO- PHARMA, S.A.

✅ Low Risk

FEI: 3003992097 • Santo Domingo De Guzman, Distrito Nacional • DOMINICAN REPUBLIC

FEI

FEI Number

3003992097

📍

Location

Santo Domingo De Guzman, Distrito Nacional

🇩🇴
🏢

Address

UNKNOW, , Santo Domingo De Guzman, Distrito Nacional, Dominican Republic

Low Risk

FDA Import Risk Assessment

23.0
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
3
Unique Violations
6/17/2008
Latest Refusal
6/17/2008
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
6/17/2008
54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
482NUTRIT LBL
488HEALTH C
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is INDO- PHARMA, S.A.'s FDA import refusal history?

INDO- PHARMA, S.A. (FEI: 3003992097) has 1 FDA import refusal record(s) in our database, spanning from 6/17/2008 to 6/17/2008.

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. INDO- PHARMA, S.A.'s FEI number is 3003992097.

What types of violations has INDO- PHARMA, S.A. received?

INDO- PHARMA, S.A. has been cited for 3 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 INDO- PHARMA, S.A. come from?

All FDA import refusal data for INDO- PHARMA, S.A. 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.