BIGFA JOINT STOCK COMPANY
⚠️ High Risk
FEI: 3016977279 • Luong Son District, Hoa Binh • VIETNAM
FEI Number
3016977279
Location
Luong Son District, Hoa Binh
Country
VIETNAMAddress
Luong Son Industrial Zone, Km36, National Highway 6, Hoa Son Commune, Luong Son District, Hoa Binh, Vietnam
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).
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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2025 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2025 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/14/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 10/14/2025 | 58PCY05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 5/9/2024 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/9/2024 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/17/2023 | 66VDH99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BIGFA JOINT STOCK COMPANY's FDA import refusal history?
BIGFA JOINT STOCK COMPANY (FEI: 3016977279) has 8 FDA import refusal record(s) in our database, spanning from 10/17/2023 to 10/17/2025.
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. BIGFA JOINT STOCK COMPANY's FEI number is 3016977279.
What types of violations has BIGFA JOINT STOCK COMPANY received?
BIGFA JOINT STOCK COMPANY has been cited for 12 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 BIGFA JOINT STOCK COMPANY come from?
All FDA import refusal data for BIGFA JOINT STOCK COMPANY 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.