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Inovia Internation

⚠️ Moderate Risk

FEI: 3005908832 • Peterborough • UNITED KINGDOM

FEI

FEI Number

3005908832

📍

Location

Peterborough

🇬🇧
🏢

Address

Unit 11, Kings Cliffe Industrial Estate; Kings Cliffe Road, Peterborough, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
2/22/2011
Latest Refusal
2/22/2011
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

3355×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

5085×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
2/22/2011
85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE
118NOT LISTED
335LACKS N/C
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/22/2011
85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE
118NOT LISTED
335LACKS N/C
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/22/2011
85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE
118NOT LISTED
335LACKS N/C
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/22/2011
85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE
118NOT LISTED
335LACKS N/C
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/22/2011
85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE
118NOT LISTED
335LACKS N/C
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Inovia Internation's FDA import refusal history?

Inovia Internation (FEI: 3005908832) has 5 FDA import refusal record(s) in our database, spanning from 2/22/2011 to 2/22/2011.

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. Inovia Internation's FEI number is 3005908832.

What types of violations has Inovia Internation received?

Inovia Internation 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 Inovia Internation come from?

All FDA import refusal data for Inovia Internation 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.