ImportRefusal LogoImportRefusal

Prabas Vcare Health Clinic

⚠️ Moderate Risk

FEI: 3010920482 • Chennai • INDIA

FEI

FEI Number

3010920482

📍

Location

Chennai

🇮🇳

Country

INDIA
🏢

Address

No 113&114 Mena Kampala Arcade, , Chennai, , India

Moderate Risk

FDA Import Risk Assessment

28.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
5
Unique Violations
8/29/2014
Latest Refusal
8/13/2014
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2182×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

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
8/29/2014
54FYY58SAW PALMETTO (HERBAL & BOTANICALS, NOT TEAS)
218LIST INGRE
488HEALTH C
Cincinnati District Office (CIN-DO)
8/29/2014
54FYY12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
218LIST INGRE
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
8/13/2014
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Prabas Vcare Health Clinic's FDA import refusal history?

Prabas Vcare Health Clinic (FEI: 3010920482) has 3 FDA import refusal record(s) in our database, spanning from 8/13/2014 to 8/29/2014.

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. Prabas Vcare Health Clinic's FEI number is 3010920482.

What types of violations has Prabas Vcare Health Clinic received?

Prabas Vcare Health Clinic 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 Prabas Vcare Health Clinic come from?

All FDA import refusal data for Prabas Vcare Health Clinic 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.