Encompass Industries Sdn. Bhd.

⚠️ High Risk

FEI: 3014384460 • Kerteh, Terengganu • MALAYSIA

FEI

FEI Number

3014384460

📍

Location

Kerteh, Terengganu

🇲🇾

Country

MALAYSIA

🏢

Address

Lot 18256 Kawasan Perindustrian Lot, Q; Kertih Bio-Polymer Park, Kerteh, Terengganu, Malaysia

High Risk

FDA Import Risk Assessment

68.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

1/7/2026

Latest Refusal

6/3/2025

Earliest Refusal

Score Breakdown

Violation Severity

61.5×40%

Refusal Volume

48.2×30%

Recency

97.0×20%

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

50817×

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.

22311×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

2605×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

4773×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

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).

39051×

3905

Refusal History

Date	Product	Violations	Division
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	260FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	260FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	260FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	260FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	260FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
1/7/2026	80LZAGLOVE, PATIENT EXAMINATION, POLY	223FALSE 508NO 510(K)	Division of West Coast Imports (DWCI)
10/10/2025	80LZAGLOVE, PATIENT EXAMINATION, POLY	118NOT LISTED 341REGISTERED 39053905 477HOLES 508NO 510(K)	Division of West Coast Imports (DWCI)
6/3/2025	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southeast Imports (DSEI)
6/3/2025	80LZAGLOVE, PATIENT EXAMINATION, POLY	477HOLES	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Encompass Industries Sdn. Bhd.'s FDA import refusal history?

Encompass Industries Sdn. Bhd. (FEI: 3014384460) has 19 FDA import refusal record(s) in our database, spanning from 6/3/2025 to 1/7/2026.

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. Encompass Industries Sdn. Bhd.'s FEI number is 3014384460.

What types of violations has Encompass Industries Sdn. Bhd. received?

Encompass Industries Sdn. Bhd. has been cited for 7 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 Encompass Industries Sdn. Bhd. come from?

All FDA import refusal data for Encompass Industries Sdn. Bhd. 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.