Zuellig Pharma Corporation
⚠️ Moderate Risk
FEI: 3001229217 • Metro Manila, National Capital Region • PHILIPPINES
FEI Number
3001229217
Location
Metro Manila, National Capital Region
Country
PHILIPPINESAddress
Sen Gil J Puyat Avenue, , Metro Manila, National Capital Region, 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).
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 |
|---|---|---|---|
| 10/9/2009 | 61GDB85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | San Francisco District Office (SAN-DO) | |
| 9/21/2009 | 61XCB09CINNARIZINE (ANTI-HISTAMINIC) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 5/7/2009 | 62ODB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 5/14/2008 | 62OBA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | San Francisco District Office (SAN-DO) | |
| 5/14/2008 | 61EBA99ANTI-ASTHMATIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/15/2007 | 64LDA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/15/2007 | 64LDA50PREDNISOLONE (GLUCOCORTICOID) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 2/16/2007 | 62FCO99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/16/2005 | 66FPA99SUPPRESSANT N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/19/2005 | 66JBC99THYROID HORMONE N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Zuellig Pharma Corporation's FDA import refusal history?
Zuellig Pharma Corporation (FEI: 3001229217) has 10 FDA import refusal record(s) in our database, spanning from 7/19/2005 to 10/9/2009.
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. Zuellig Pharma Corporation's FEI number is 3001229217.
What types of violations has Zuellig Pharma Corporation received?
Zuellig Pharma Corporation 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 Zuellig Pharma Corporation come from?
All FDA import refusal data for Zuellig Pharma Corporation 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.