SHENZHEN MASON VAP TECHNOLOGY CO., LTD.
⚠️ Moderate Risk
FEI: 3014121250 • Shenzhen, Guangdong • CHINA
FEI Number
3014121250
Location
Shenzhen, Guangdong
Country
CHINAAddress
East Of Building B1, Guangyao Industrial Park, No. 18 Fourth Industrial Zone, Zhulongtian Road F/2 F/3, Shuitian; Baoancomumunity, Shenzhen, Guangdong, China
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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.
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. 801.15(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.
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/29/2020 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 10/9/2019 | 79OAPLASER, COMB, HAIR | Division of Northeast Imports (DNEI) | |
| 10/9/2019 | 64LBO13DEXAMETHASONE ACETATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 10/9/2019 | 55PY85CINNAMON OIL (PHARMACEUTIC NECESSITY - FLAVOR) | Division of Northeast Imports (DNEI) | |
| 10/9/2019 | 66YBD99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/9/2019 | 66YBD99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/9/2019 | 27YHY06PEPPER SAUCE (HOT, MILD, ETC.) | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 10/9/2019 | 62MAD01CAMPHOR (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is SHENZHEN MASON VAP TECHNOLOGY CO., LTD.'s FDA import refusal history?
SHENZHEN MASON VAP TECHNOLOGY CO., LTD. (FEI: 3014121250) has 8 FDA import refusal record(s) in our database, spanning from 10/9/2019 to 7/29/2020.
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. SHENZHEN MASON VAP TECHNOLOGY CO., LTD.'s FEI number is 3014121250.
What types of violations has SHENZHEN MASON VAP TECHNOLOGY CO., LTD. received?
SHENZHEN MASON VAP TECHNOLOGY CO., LTD. has been cited for 8 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 SHENZHEN MASON VAP TECHNOLOGY CO., LTD. come from?
All FDA import refusal data for SHENZHEN MASON VAP TECHNOLOGY CO., LTD. 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.