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Parle Agro Pvt Ltd

⚠️ Moderate Risk

FEI: 3008976374 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3008976374

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

Andheri West, , Mumbai, Maharashtra, 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
1
Unique Violations
11/18/2015
Latest Refusal
11/18/2015
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

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
11/18/2015
21VCT05MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Parle Agro Pvt Ltd's FDA import refusal history?

Parle Agro Pvt Ltd (FEI: 3008976374) has 1 FDA import refusal record(s) in our database, spanning from 11/18/2015 to 11/18/2015.

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. Parle Agro Pvt Ltd's FEI number is 3008976374.

What types of violations has Parle Agro Pvt Ltd received?

Parle Agro Pvt Ltd has been cited for 1 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 Parle Agro Pvt Ltd come from?

All FDA import refusal data for Parle Agro Pvt 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.