Encompass Industries Sdn. Bhd.
⚠️ Moderate Risk
FEI: 3014384460 • Kerteh, Terengganu • MALAYSIA
FEI Number
3014384460
Location
Kerteh, Terengganu
Country
MALAYSIAAddress
Lot 18256 Kawasan Perindustrian Lot, Q; Kertih Bio-Polymer Park, Kerteh, Terengganu, Malaysia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
© ImportRefusal.com Original Analysis
Violation Summary
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
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).
3905
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.
Refusal History
Frequently Asked Questions
What is Encompass Industries Sdn. Bhd.'s FDA import refusal history?
Encompass Industries Sdn. Bhd. (FEI: 3014384460) has 3 FDA import refusal record(s) in our database, spanning from 6/3/2025 to 10/10/2025.
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 5 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.