Skynet Interntional
⚠️ High Risk
FEI: 3003942417 • Manila • PHILIPPINES
FEI Number
3003942417
Location
Manila
Country
PHILIPPINESAddress
3333 New Panaderos St, , Manila, , Philippines
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 6/2/2005 | 66MDA03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/21/2005 | 61PDA31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/21/2005 | 62ODA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/21/2005 | 61JDA99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/21/2005 | 61LDA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/21/2005 | 66SDA48ISOSORBIDE MONONITRATE (VASODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/21/2005 | 66RDA99VASOCONSTRICTOR N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/29/2004 | 60LAY99ANALGESIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/23/2004 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Skynet Interntional's FDA import refusal history?
Skynet Interntional (FEI: 3003942417) has 9 FDA import refusal record(s) in our database, spanning from 7/23/2004 to 6/2/2005.
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. Skynet Interntional's FEI number is 3003942417.
What types of violations has Skynet Interntional received?
Skynet Interntional has been cited for 4 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 Skynet Interntional come from?
All FDA import refusal data for Skynet Interntional 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.