East Asia Laboratories Inc
⚠️ Moderate Risk
FEI: 3012092641 • San Mateo, Calabarzon • PHILIPPINES
FEI Number
3012092641
Location
San Mateo, Calabarzon
Country
PHILIPPINESAddress
Saint Mathew, St Marvi Hills Sub, San Mateo, Calabarzon, Philippines
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
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2023 | 56BKA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 1/13/2022 | 60ZPY16LEVAMISOLE HYDROCHLORIDE (ANTIPARASITIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 12/6/2021 | 66VLY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/6/2021 | 66VLY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/26/2021 | 56YPY99ANTIBIOTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 2/26/2021 | 56YPY99ANTIBIOTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 2/26/2021 | 56YPY99ANTIBIOTIC N.E.C. | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 2/26/2021 | 56YPY99ANTIBIOTIC N.E.C. | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 8/28/2020 | 60ZPC29PRAZIQUANTEL (ANTIPARASITIC) | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 8/28/2020 | 56YPC99ANTIBIOTIC N.E.C. | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is East Asia Laboratories Inc's FDA import refusal history?
East Asia Laboratories Inc (FEI: 3012092641) has 10 FDA import refusal record(s) in our database, spanning from 8/28/2020 to 4/11/2023.
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. East Asia Laboratories Inc's FEI number is 3012092641.
What types of violations has East Asia Laboratories Inc received?
East Asia Laboratories Inc 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 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.