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ANEROS (HIGH ISLAND HEALTH)

✅ Low Risk

FEI: 3011918067 • Houston, TX • UNITED STATES

FEI

FEI Number

3011918067

📍

Location

Houston, TX

🇺🇸
🏢

Address

1800 Silber Rd, , Houston, TX, United States

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/30/2015
Latest Refusal
12/30/2015
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

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).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
12/30/2015
61HBY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
333LACKS FIRM
483DRUG NAME
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is ANEROS (HIGH ISLAND HEALTH)'s FDA import refusal history?

ANEROS (HIGH ISLAND HEALTH) (FEI: 3011918067) has 1 FDA import refusal record(s) in our database, spanning from 12/30/2015 to 12/30/2015.

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. ANEROS (HIGH ISLAND HEALTH)'s FEI number is 3011918067.

What types of violations has ANEROS (HIGH ISLAND HEALTH) received?

ANEROS (HIGH ISLAND HEALTH) 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 ANEROS (HIGH ISLAND HEALTH) come from?

All FDA import refusal data for ANEROS (HIGH ISLAND HEALTH) 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.