AMK Food Export (Pvt) Ltd

⚠️ High Risk

FEI: 3006707635 • Homagama, Colombo • SRI LANKA

FEI

FEI Number

3006707635

📍

Location

Homagama, Colombo

🇱🇰

Country

SRI LANKA

🏢

Address

Homagama, 62, Katuwana Industrial Zone, Homagama, Colombo, Sri Lanka

High Risk

FDA Import Risk Assessment

52.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/12/2023

Latest Refusal

6/10/2009

Earliest Refusal

Score Breakdown

Violation Severity

65.3×40%

Refusal Volume

50.4×30%

Recency

48.4×20%

Frequency

15.7×10%

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

3216×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

4826×

NUTRIT LBL

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 fails to bear the required nutrition information.

2495×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

94×

SALMONELLA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.

2743×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

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).

832×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

621×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

2411×

PESTICIDE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:

Refusal History

Date	Product	Violations	Division
6/12/2023	24AGT70LENTILS	241PESTICIDE	Division of West Coast Imports (DWCI)
6/9/2022	21XGT14TAMARIND (SUBTROPICAL/TROPICAL FRUIT PULP)	249FILTHY	Division of West Coast Imports (DWCI)
5/17/2021	28FGT04CURRY POWDER, GROUND, CRACKED, WITHOUT SALT	482NUTRIT LBL	Division of Northeast Imports (DNEI)
5/17/2021	28FGT04CURRY POWDER, GROUND, CRACKED, WITHOUT SALT	482NUTRIT LBL	Division of Northeast Imports (DNEI)
12/9/2020	21TYH14TAMARIND, DRIED OR PASTE	249FILTHY	Division of Northeast Imports (DNEI)
3/13/2019	03YCT99OTHER BAKERY PRODUCTS, N.E.C.	321LACKS N/C 482NUTRIT LBL	Division of West Coast Imports (DWCI)
3/13/2019	03YCT99OTHER BAKERY PRODUCTS, N.E.C.	321LACKS N/C 482NUTRIT LBL	Division of West Coast Imports (DWCI)
3/13/2019	26CCT01COCONUT OIL, REFINED, SINGLE INGREDIENT	321LACKS N/C 482NUTRIT LBL	Division of West Coast Imports (DWCI)
3/13/2019	02JCT03MALT, WHEAT	274COLOR LBLG 321LACKS N/C 482NUTRIT LBL	Division of West Coast Imports (DWCI)
3/13/2019	03SGT40PIE (FRUIT, PUMPKIN, PECAN, ETC.) AND PUDDING PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING	274COLOR LBLG 321LACKS N/C	Division of West Coast Imports (DWCI)
3/13/2019	33YGT99CANDY WITHOUT CHOCOLATE N.E.C.	274COLOR LBLG 321LACKS N/C	Division of West Coast Imports (DWCI)
5/4/2016	28BCT54PEPPER, BLACK, GROUND, CRACKED (SPICE)	9SALMONELLA	Los Angeles District Office (LOS-DO)
5/4/2016	28BGT54PEPPER, BLACK, GROUND, CRACKED (SPICE)	9SALMONELLA	Los Angeles District Office (LOS-DO)
1/29/2013	53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.	75UNAPPROVED	Los Angeles District Office (LOS-DO)
1/29/2013	65CBY99NUTRIENT/TONIC N.E.C.	75UNAPPROVED	Los Angeles District Office (LOS-DO)
12/14/2012	37KCE99PASTES, N.E.C.	62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
12/6/2012	02DGT02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)	249FILTHY	Los Angeles District Office (LOS-DO)
12/6/2012	28BGT54PEPPER, BLACK, GROUND, CRACKED (SPICE)	9SALMONELLA	Los Angeles District Office (LOS-DO)
12/6/2012	28BGT54PEPPER, BLACK, GROUND, CRACKED (SPICE)	9SALMONELLA	Los Angeles District Office (LOS-DO)
6/4/2012	02DGT01RICE, BROWN, PROCESSED (PACKAGED)	249FILTHY	Los Angeles District Office (LOS-DO)
3/15/2012	22HGT99OTHER FRUIT AND FRUIT PRODUCTS, DRIED AND PASTE, N.E.C.	249FILTHY	Los Angeles District Office (LOS-DO)
6/10/2009	16YCE99FISHERY PRODUCTS, N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is AMK Food Export (Pvt) Ltd's FDA import refusal history?

AMK Food Export (Pvt) Ltd (FEI: 3006707635) has 22 FDA import refusal record(s) in our database, spanning from 6/10/2009 to 6/12/2023.

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. AMK Food Export (Pvt) Ltd's FEI number is 3006707635.

What types of violations has AMK Food Export (Pvt) Ltd received?

AMK Food Export (Pvt) Ltd has been cited for 9 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 AMK Food Export (Pvt) Ltd come from?

All FDA import refusal data for AMK Food Export (Pvt) Ltd 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.