ImportRefusal LogoImportRefusal

Synergene Active Ingredients Pvt. Ltd. (Unit II)

⚠️ Moderate Risk

FEI: 3010634351 • Visakhapatnam, Andhra Pradesh • INDIA

FEI

FEI Number

3010634351

📍

Location

Visakhapatnam, Andhra Pradesh

🇮🇳

Country

INDIA
🏢

Address

Plot No 59d Jawaharlal Nehru, Pharma City; Parawada Mandal, Visakhapatnam, Andhra Pradesh, India

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/20/2018
Latest Refusal
9/20/2018
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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.

Refusal History

DateProductViolationsDivision
9/20/2018
61WOZ45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
118NOT LISTED
16DIRECTIONS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Synergene Active Ingredients Pvt. Ltd. (Unit II)'s FDA import refusal history?

Synergene Active Ingredients Pvt. Ltd. (Unit II) (FEI: 3010634351) has 1 FDA import refusal record(s) in our database, spanning from 9/20/2018 to 9/20/2018.

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. Synergene Active Ingredients Pvt. Ltd. (Unit II)'s FEI number is 3010634351.

What types of violations has Synergene Active Ingredients Pvt. Ltd. (Unit II) received?

Synergene Active Ingredients Pvt. Ltd. (Unit II) 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 Synergene Active Ingredients Pvt. Ltd. (Unit II) come from?

All FDA import refusal data for Synergene Active Ingredients Pvt. Ltd. (Unit II) 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.