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SPITEX EXPORTS OPC

Low Risk

FEI: 3021736489 • Pune • INDIA

FEI

FEI Number

3021736489

📍

Location

Pune

🇮🇳

Country

INDIA
🏢

Address

C2k Flat No 902 S, , Pune, , India

Low Risk

FDA Import Risk Assessment

18.4
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
3/28/2022
Latest Refusal
3/28/2022
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
10.1×20%
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

3201×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3211×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
3/28/2022
28CYT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE)
320LACKS FIRM
321LACKS N/C
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SPITEX EXPORTS OPC's FDA import refusal history?

SPITEX EXPORTS OPC (FEI: 3021736489) has 1 FDA import refusal record(s) in our database, spanning from 3/28/2022 to 3/28/2022.

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. SPITEX EXPORTS OPC's FEI number is 3021736489.

What types of violations has SPITEX EXPORTS OPC received?

SPITEX EXPORTS OPC 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 SPITEX EXPORTS OPC come from?

All FDA import refusal data for SPITEX EXPORTS OPC 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.