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Veronika Pollard

⚠️ Moderate Risk

FEI: 3008299086 • Didcot, Oxfordshire • UNITED KINGDOM

FEI

FEI Number

3008299086

📍

Location

Didcot, Oxfordshire

🇬🇧
🏢

Address

Unit A, Park; 34 Collett, Didcot, Oxfordshire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

43.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/29/2013
Latest Refusal
4/13/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
17.8×10%
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

711×

NO LICENSE

The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use

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
5/29/2013
55RP99PHARMACEUTIC NECESSITIES, N.E.C.
75UNAPPROVED
Philadelphia District Office (PHI-DO)
4/13/2012
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
71NO LICENSE
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Veronika Pollard's FDA import refusal history?

Veronika Pollard (FEI: 3008299086) has 2 FDA import refusal record(s) in our database, spanning from 4/13/2012 to 5/29/2013.

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. Veronika Pollard's FEI number is 3008299086.

What types of violations has Veronika Pollard received?

Veronika Pollard 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 Veronika Pollard come from?

All FDA import refusal data for Veronika Pollard 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.