ImportRefusal LogoImportRefusal

JYOTHI LABORATORIES LTD

⚠️ Moderate Risk

FEI: 3013189100 • UTTRAKHAND • INDIA

FEI

FEI Number

3013189100

📍

Location

UTTRAKHAND

🇮🇳

Country

INDIA
🏢

Address

PLOT NO. 6,7&8 BEARING, 361, 366, 370 KIE INDUSTRIAL ES, UTTRAKHAND, , India

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/14/2018
Latest Refusal
12/14/2018
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1781×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

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
12/14/2018
63RAL06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
178COL ADDED
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is JYOTHI LABORATORIES LTD's FDA import refusal history?

JYOTHI LABORATORIES LTD (FEI: 3013189100) has 1 FDA import refusal record(s) in our database, spanning from 12/14/2018 to 12/14/2018.

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. JYOTHI LABORATORIES LTD's FEI number is 3013189100.

What types of violations has JYOTHI LABORATORIES LTD received?

JYOTHI LABORATORIES LTD 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 JYOTHI LABORATORIES LTD come from?

All FDA import refusal data for JYOTHI LABORATORIES LTD 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.