Perfect Idea China Limited
⚠️ Moderate Risk
FEI: 3010572682 • Shenzhen, Guangdong • CHINA
FEI Number
3010572682
Location
Shenzhen, Guangdong
Country
CHINAAddress
Floor 6, A2 Jinxiangfu Ind Zone, 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
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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/26/2017 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 3/31/2017 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 5/21/2014 | 89IMGSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) | |
| 5/13/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Cincinnati District Office (CIN-DO) | |
| 2/10/2014 | 79GFEBRUSH, DERMABRASION | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Perfect Idea China Limited's FDA import refusal history?
Perfect Idea China Limited (FEI: 3010572682) has 5 FDA import refusal record(s) in our database, spanning from 2/10/2014 to 6/26/2017.
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. Perfect Idea China Limited's FEI number is 3010572682.
What types of violations has Perfect Idea China Limited received?
Perfect Idea China Limited 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 Perfect Idea China Limited come from?
All FDA import refusal data for Perfect Idea China Limited 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.