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Ups Co. Suc. Bolivia

⚠️ Moderate Risk

FEI: 3004021459 • La Paz • BOLIVIA

FEI

FEI Number

3004021459

📍

Location

La Paz

🇧🇴

Country

BOLIVIA
🏢

Address

Av 6 De Agosto Edif. Hilda P4 Of 401, , La Paz, , Bolivia

Moderate Risk

FDA Import Risk Assessment

41.6
LowModerateHighCritical

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

Statistics

10
Total Refusals
3
Unique Violations
7/14/2003
Latest Refusal
7/14/2003
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

3418×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5088×

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.

1182×

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
7/14/2003
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
7/14/2003
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
7/14/2003
87KWKAPPLIANCE, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
7/14/2003
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
7/14/2003
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
7/14/2003
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
7/14/2003
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
7/14/2003
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
508NO 510(K)
Florida District Office (FLA-DO)
7/14/2003
68FYY99OTHER ANIMAL, N.E.C. HORMONES
118NOT LISTED
Florida District Office (FLA-DO)
7/14/2003
68FYY99OTHER ANIMAL, N.E.C. HORMONES
118NOT LISTED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Ups Co. Suc. Bolivia's FDA import refusal history?

Ups Co. Suc. Bolivia (FEI: 3004021459) has 10 FDA import refusal record(s) in our database, spanning from 7/14/2003 to 7/14/2003.

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. Ups Co. Suc. Bolivia's FEI number is 3004021459.

What types of violations has Ups Co. Suc. Bolivia received?

Ups Co. Suc. Bolivia 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 Ups Co. Suc. Bolivia come from?

All FDA import refusal data for Ups Co. Suc. Bolivia 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.