ImportRefusal LogoImportRefusal

The Westing Playa Bonita Panama

✅ Low Risk

FEI: 3010039132 • Pamama • PANAMA

FEI

FEI Number

3010039132

📍

Location

Pamama

🇵🇦

Country

PANAMA
🏢

Address

Kilometro 6 Camino A Veracruz, , Pamama, , Panama

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/19/2013
Latest Refusal
3/19/2013
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

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).

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
3/19/2013
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
Florida District Office (FLA-DO)

Frequently Asked Questions

What is The Westing Playa Bonita Panama's FDA import refusal history?

The Westing Playa Bonita Panama (FEI: 3010039132) has 1 FDA import refusal record(s) in our database, spanning from 3/19/2013 to 3/19/2013.

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. The Westing Playa Bonita Panama's FEI number is 3010039132.

What types of violations has The Westing Playa Bonita Panama received?

The Westing Playa Bonita Panama 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 The Westing Playa Bonita Panama come from?

All FDA import refusal data for The Westing Playa Bonita Panama 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.