AGROINDUSTRIAS KAPAK HUAYTA SAC

⚠️ Moderate Risk

FEI: 3010909812 • Lima, Lima • PERU

FEI

FEI Number

3010909812

📍

Location

Lima, Lima

🇵🇪

Country

PERU

🏢

Address

Manzana F Lote 5 Sec Pampa Grande, (Ex Fundo Casica El Olivar) Pachacamac, Lima, Lima, Peru

Moderate Risk

FDA Import Risk Assessment

44.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/15/2014

Latest Refusal

12/15/2014

Earliest Refusal

Score Breakdown

Violation Severity

75.8×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

2385×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

4884×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

752×

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).

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

Refusal History

Date	Product	Violations	Division
12/15/2014	41YGT99DIETARY CONVENTIONAL FOODS, N.E.C.	238UNSAFE ADD 488HEALTH C 75UNAPPROVED	Seattle District Office (SEA-DO)
12/15/2014	41YGT99DIETARY CONVENTIONAL FOODS, N.E.C.	238UNSAFE ADD 488HEALTH C 75UNAPPROVED	Seattle District Office (SEA-DO)
12/15/2014	41YGT99DIETARY CONVENTIONAL FOODS, N.E.C.	238UNSAFE ADD 488HEALTH C	Seattle District Office (SEA-DO)
12/15/2014	41YGT99DIETARY CONVENTIONAL FOODS, N.E.C.	238UNSAFE ADD 488HEALTH C	Seattle District Office (SEA-DO)
12/15/2014	41YGT99DIETARY CONVENTIONAL FOODS, N.E.C.	218LIST INGRE 238UNSAFE ADD	Seattle District Office (SEA-DO)

Frequently Asked Questions

What is AGROINDUSTRIAS KAPAK HUAYTA SAC's FDA import refusal history?

AGROINDUSTRIAS KAPAK HUAYTA SAC (FEI: 3010909812) has 5 FDA import refusal record(s) in our database, spanning from 12/15/2014 to 12/15/2014.

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. AGROINDUSTRIAS KAPAK HUAYTA SAC's FEI number is 3010909812.

What types of violations has AGROINDUSTRIAS KAPAK HUAYTA SAC received?

AGROINDUSTRIAS KAPAK HUAYTA SAC has been cited for 4 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 AGROINDUSTRIAS KAPAK HUAYTA SAC come from?

All FDA import refusal data for AGROINDUSTRIAS KAPAK HUAYTA 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.