Greenstone Pharmaceutical HK Inc.
⚠️ Moderate Risk
FEI: 3005310397 • Imus, CAVITE • PHILIPPINES
FEI Number
3005310397
Location
Imus, CAVITE
Country
PHILIPPINESAddress
I.C. Anabu Hills Industrial Estate, , Imus, CAVITE, Philippines
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 5/21/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 1/16/2008 | 62FBJ46CAMPHORATED PARACHLOROPHENOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/16/2008 | 62FBJ46CAMPHORATED PARACHLOROPHENOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 1/16/2008 | 62FBJ46CAMPHORATED PARACHLOROPHENOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Greenstone Pharmaceutical HK Inc.'s FDA import refusal history?
Greenstone Pharmaceutical HK Inc. (FEI: 3005310397) has 5 FDA import refusal record(s) in our database, spanning from 1/16/2008 to 9/18/2013.
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. Greenstone Pharmaceutical HK Inc.'s FEI number is 3005310397.
What types of violations has Greenstone Pharmaceutical HK Inc. received?
Greenstone Pharmaceutical HK Inc. has been cited for 2 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 Greenstone Pharmaceutical HK Inc. come from?
All FDA import refusal data for Greenstone Pharmaceutical HK Inc. 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.