VRG KHAI HOAN JOINT STOCK COMPANY
⚠️ Moderate Risk
FEI: 3007048214 • BEN CAT • VIETNAM
FEI Number
3007048214
Location
BEN CAT
Country
VIETNAMAddress
CAU SAT HAMLET, LAI HUNG COMMUNE, , BEN CAT, , Vietnam
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).
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/21/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of West Coast Imports (DWCI) | |
| 9/18/2017 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Northern Border Imports (DNBI) | |
| 9/18/2017 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Northern Border Imports (DNBI) | |
| 9/18/2017 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Northern Border Imports (DNBI) | |
| 10/17/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
| 10/3/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 10/3/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 10/3/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 10/3/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 10/3/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 9/23/2013 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is VRG KHAI HOAN JOINT STOCK COMPANY's FDA import refusal history?
VRG KHAI HOAN JOINT STOCK COMPANY (FEI: 3007048214) has 11 FDA import refusal record(s) in our database, spanning from 9/23/2013 to 12/21/2021.
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. VRG KHAI HOAN JOINT STOCK COMPANY's FEI number is 3007048214.
What types of violations has VRG KHAI HOAN JOINT STOCK COMPANY received?
VRG KHAI HOAN JOINT STOCK COMPANY 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 VRG KHAI HOAN JOINT STOCK COMPANY come from?
All FDA import refusal data for VRG KHAI HOAN 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.