ADI INDUSTRY CO LIMITED
⚠️ Moderate Risk
FEI: 3018057708 • Kowloon Bay, Kowloon • HONG KONG
FEI Number
3018057708
Location
Kowloon Bay, Kowloon
Country
HONG KONGAddress
Chevalier Commercial Centre 2 D2 Room, 8 Wang Hoi Road, Kowloon Bay, Kowloon, Hong Kong
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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2021 | 65PBA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 65PBA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 65PBA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 65PBA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 65PBA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 65PBA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 65PBA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 65PBA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 65PBA02SILDENAFIL CITRATE (REGULATOR) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ADI INDUSTRY CO LIMITED's FDA import refusal history?
ADI INDUSTRY CO LIMITED (FEI: 3018057708) has 9 FDA import refusal record(s) in our database, spanning from 5/6/2021 to 5/6/2021.
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. ADI INDUSTRY CO LIMITED's FEI number is 3018057708.
What types of violations has ADI INDUSTRY CO LIMITED received?
ADI INDUSTRY CO 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 ADI INDUSTRY CO LIMITED come from?
All FDA import refusal data for ADI INDUSTRY CO 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.