Laboratorios Kaita Del Peru Sac

⚠️ Moderate Risk

FEI: 3009537746 • Lima • PERU

FEI

FEI Number

3009537746

📍

Location

Lima

🇵🇪

Country

PERU

🏢

Address

Av 27 Deciembre Mz Q1 Tablada 2 Zonas, , Lima, , Peru

Moderate Risk

FDA Import Risk Assessment

49.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/6/2013

Latest Refusal

2/6/2013

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

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

Violation Summary

11810×

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).

7510×

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

Date	Product	Violations	Division
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)
2/6/2013	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Laboratorios Kaita Del Peru Sac's FDA import refusal history?

Laboratorios Kaita Del Peru Sac (FEI: 3009537746) has 10 FDA import refusal record(s) in our database, spanning from 2/6/2013 to 2/6/2013.

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. Laboratorios Kaita Del Peru Sac's FEI number is 3009537746.

What types of violations has Laboratorios Kaita Del Peru Sac received?

Laboratorios Kaita Del Peru Sac 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 Laboratorios Kaita Del Peru Sac come from?

All FDA import refusal data for Laboratorios Kaita Del Peru Sac 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.