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PHARMA BIOLOGICAL

⚠️ High Risk

FEI: 3019756808 • Jaipur • INDIA

FEI

FEI Number

3019756808

📍

Location

Jaipur

🇮🇳

Country

INDIA
🏢

Address

G-104, Ricco Industrialarea Prahladpura, Tonk Road, Jaipur, , India

High Risk

FDA Import Risk Assessment

68.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

6
Total Refusals
3
Unique Violations
12/22/2025
Latest Refusal
9/17/2024
Earliest Refusal

Score Breakdown

Violation Severity
86.0×40%
Refusal Volume
31.3×30%
Recency
99.0×20%
Frequency
47.5×10%
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

756×

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).

113×

UNSAFE COL

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

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).

Refusal History

DateProductViolationsDivision
12/22/2025
54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/20/2025
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/5/2025
54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/11/2025
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/3/2025
54FCA12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
11UNSAFE COL
75UNAPPROVED
Division of Northeast Imports (DNEI)
9/17/2024
60FDY01KAOLIN (ADSORBANT)
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is PHARMA BIOLOGICAL's FDA import refusal history?

PHARMA BIOLOGICAL (FEI: 3019756808) has 6 FDA import refusal record(s) in our database, spanning from 9/17/2024 to 12/22/2025.

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. PHARMA BIOLOGICAL's FEI number is 3019756808.

What types of violations has PHARMA BIOLOGICAL received?

PHARMA BIOLOGICAL has been cited for 3 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 PHARMA BIOLOGICAL come from?

All FDA import refusal data for PHARMA BIOLOGICAL 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.