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Salud Integral

⚠️ Moderate Risk

FEI: 3011250451 • Tegucigalpategucigalpa • HONDURAS

FEI

FEI Number

3011250451

📍

Location

Tegucigalpategucigalpa

🇭🇳

Country

HONDURAS
🏢

Address

Blvd. Suyapa , Edificio Metropolis Torre, , Tegucigalpategucigalpa, , Honduras

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/12/2015
Latest Refusal
11/12/2015
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

272×

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).

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).

Refusal History

DateProductViolationsDivision
11/12/2015
65FAK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/12/2015
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Salud Integral's FDA import refusal history?

Salud Integral (FEI: 3011250451) has 2 FDA import refusal record(s) in our database, spanning from 11/12/2015 to 11/12/2015.

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. Salud Integral's FEI number is 3011250451.

What types of violations has Salud Integral received?

Salud Integral 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 Salud Integral come from?

All FDA import refusal data for Salud Integral 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.