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DR. RECKEWEG CARBO VEG DILUTION

⚠️ Moderate Risk

FEI: 3027577143 • Gurugram, Haryana • INDIA

FEI

FEI Number

3027577143

📍

Location

Gurugram, Haryana

🇮🇳

Country

INDIA
🏢

Address

5th Floor, 46/4 M Tower B, Gurugram, Haryana, India

Moderate Risk

FDA Import Risk Assessment

42.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/18/2023
Latest Refusal
8/18/2023
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
51.4×20%
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).

751×

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
8/18/2023
66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is DR. RECKEWEG CARBO VEG DILUTION's FDA import refusal history?

DR. RECKEWEG CARBO VEG DILUTION (FEI: 3027577143) has 1 FDA import refusal record(s) in our database, spanning from 8/18/2023 to 8/18/2023.

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. DR. RECKEWEG CARBO VEG DILUTION's FEI number is 3027577143.

What types of violations has DR. RECKEWEG CARBO VEG DILUTION received?

DR. RECKEWEG CARBO VEG DILUTION 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 DR. RECKEWEG CARBO VEG DILUTION come from?

All FDA import refusal data for DR. RECKEWEG CARBO VEG DILUTION 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.