East Asia Laboratories Inc
⚠️ High Risk
FEI: 3012084257 • San Mateo Rizal • MALAYSIA
FEI Number
3012084257
Location
San Mateo Rizal
Country
MALAYSIAAddress
Saint Mathew, Saint Marvi Hills Subd, , San Mateo Rizal, , Malaysia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/21/2022 | 54ARY08PANTOTHENIC ACID (PANTHENOL) (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/21/2022 | 60ZMY29PRAZIQUANTEL (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/21/2022 | 54YNY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/21/2022 | 56BMY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/21/2022 | 54ANY13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/19/2018 | 56BRR03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/19/2018 | 61GRL16NIFURTHIAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/25/2016 | 54ANB16VITAMIN E (TOCOPHEROL) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 3/25/2016 | 56BKA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 2/26/2016 | 56BXY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is East Asia Laboratories Inc's FDA import refusal history?
East Asia Laboratories Inc (FEI: 3012084257) has 10 FDA import refusal record(s) in our database, spanning from 2/26/2016 to 6/21/2022.
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. East Asia Laboratories Inc's FEI number is 3012084257.
What types of violations has East Asia Laboratories Inc received?
East Asia Laboratories Inc 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 East Asia Laboratories Inc come from?
All FDA import refusal data for East Asia Laboratories Inc 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.