Fito Peru Export Import Sac

⚠️ High Risk

FEI: 3003991676 • Santa Anita - Lima • PERU

FEI

FEI Number

3003991676

📍

Location

Santa Anita - Lima

🇵🇪

Country

PERU

🏢

Address

Av 2 B9 6 Asoc Viv Resd Sta Anita, , Santa Anita - Lima, , Peru

High Risk

FDA Import Risk Assessment

53.5

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

8/12/2010

Latest Refusal

1/8/2004

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

Refusal Volume

61.9×30%

Recency

0.0×20%

Frequency

69.7×10%

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

11846×

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).

7546×

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
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	66VCS99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
8/12/2010	54ECT99HERBALS & BOTANICAL TEAS, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/27/2004	62FBY99ANTI-INFECTIVE, TOPICAL N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
9/27/2004	61WBK99A-FUNGAL N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
1/8/2004	60LBY99ANALGESIC, N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
1/8/2004	61WBK99A-FUNGAL N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
1/8/2004	62FBY99ANTI-INFECTIVE, TOPICAL N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Fito Peru Export Import Sac's FDA import refusal history?

Fito Peru Export Import Sac (FEI: 3003991676) has 46 FDA import refusal record(s) in our database, spanning from 1/8/2004 to 8/12/2010.

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. Fito Peru Export Import Sac's FEI number is 3003991676.

What types of violations has Fito Peru Export Import Sac received?

Fito Peru Export Import 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 Fito Peru Export Import Sac come from?

All FDA import refusal data for Fito Peru Export Import 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.