Shenzhen Ocity Times Technology CO., LTD
⚠️ Moderate Risk
FEI: 3011816310 • Shenzhen, Guangdong • CHINA
FEI Number
3011816310
Location
Shenzhen, Guangdong
Country
CHINAAddress
Mingyou Purchasing Centre Room B542, No. 168 Baoyuan Road; Baoan, 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
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/26/2021 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/22/2020 | 98LAA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 11/4/2020 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/2/2018 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Shenzhen Ocity Times Technology CO., LTD's FDA import refusal history?
Shenzhen Ocity Times Technology CO., LTD (FEI: 3011816310) has 4 FDA import refusal record(s) in our database, spanning from 8/2/2018 to 1/26/2021.
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. Shenzhen Ocity Times Technology CO., LTD's FEI number is 3011816310.
What types of violations has Shenzhen Ocity Times Technology CO., LTD received?
Shenzhen Ocity Times Technology CO., LTD has been cited for 6 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 Ocity Times Technology CO., LTD come from?
All FDA import refusal data for Shenzhen Ocity Times 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.