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Positive Homeopathy

✅ Low Risk

FEI: 3012097215 • Chennai, Tamil Nadu • INDIA

FEI

FEI Number

3012097215

📍

Location

Chennai, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

No 338/8 H Block Sunshine Apart, Anna Nagar, Chennai, Tamil Nadu, India

Low Risk

FDA Import Risk Assessment

22.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
5
Unique Violations
3/1/2016
Latest Refusal
3/1/2016
Earliest Refusal

Score Breakdown

Violation Severity
46.0×40%
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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

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
3/1/2016
66VDA99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
16DIRECTIONS
333LACKS FIRM
335LACKS N/C
483DRUG NAME
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Positive Homeopathy's FDA import refusal history?

Positive Homeopathy (FEI: 3012097215) has 1 FDA import refusal record(s) in our database, spanning from 3/1/2016 to 3/1/2016.

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. Positive Homeopathy's FEI number is 3012097215.

What types of violations has Positive Homeopathy received?

Positive Homeopathy has been cited for 5 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 Positive Homeopathy come from?

All FDA import refusal data for Positive Homeopathy 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.