Pfizer, Inc.
⚠️ Moderate Risk
FEI: 3003817485 • Makati City • PHILIPPINES
FEI Number
3003817485
Location
Makati City
Country
PHILIPPINESAddress
6811 Ayala Ave, , Makati City, , 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
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).
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 |
|---|---|---|---|
| 1/15/2009 | 61NCE69GABAPENTIN (ANTI-DEPRESSANT) | San Francisco District Office (SAN-DO) | |
| 6/10/2008 | 65KCA09MISOPROSTOL (PROSTAGLANDIN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/11/2007 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 11/1/2005 | 61PCC09GLIPIZIDE (ANTI-DIABETIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 4/14/2005 | 62GDY48MEFENAMIC ACID (ANTI-INFLAMMATORY) | San Francisco District Office (SAN-DO) | |
| 4/14/2005 | 62CDY99ANTI-HYPERTENSIVE N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/10/2003 | 63XDB99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Pfizer, Inc.'s FDA import refusal history?
Pfizer, Inc. (FEI: 3003817485) has 7 FDA import refusal record(s) in our database, spanning from 7/10/2003 to 1/15/2009.
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. Pfizer, Inc.'s FEI number is 3003817485.
What types of violations has Pfizer, Inc. received?
Pfizer, Inc. has been cited for 3 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 Pfizer, Inc. come from?
All FDA import refusal data for Pfizer, 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.