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KIMBERLY-CLARK PERU S.R.L. - SANTA CLARA MILL

⚠️ Moderate Risk

FEI: 3007697999 • LIMA • PERU

FEI

FEI Number

3007697999

📍

Location

LIMA

🇵🇪

Country

PERU
🏢

Address

NICOLAS AYLLON AVE. NO. 8400 ATE-VITARTE, , LIMA, , Peru

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/14/2017
Latest Refusal
12/14/2017
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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).

5081×

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
12/14/2017
85HEBTAMPON, MENSTRUAL, UNSCENTED
118NOT LISTED
508NO 510(K)
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is KIMBERLY-CLARK PERU S.R.L. - SANTA CLARA MILL's FDA import refusal history?

KIMBERLY-CLARK PERU S.R.L. - SANTA CLARA MILL (FEI: 3007697999) has 1 FDA import refusal record(s) in our database, spanning from 12/14/2017 to 12/14/2017.

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. KIMBERLY-CLARK PERU S.R.L. - SANTA CLARA MILL's FEI number is 3007697999.

What types of violations has KIMBERLY-CLARK PERU S.R.L. - SANTA CLARA MILL received?

KIMBERLY-CLARK PERU S.R.L. - SANTA CLARA MILL 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 KIMBERLY-CLARK PERU S.R.L. - SANTA CLARA MILL come from?

All FDA import refusal data for KIMBERLY-CLARK PERU S.R.L. - SANTA CLARA MILL 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.