PFIZER SA DE CV
⚠️ High Risk
FEI: 3012913761 • Toluca • MEXICO
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2019 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2019 | 61MCY99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/4/2019 | 54ADB99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 65JCL21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/16/2019 | 56ECB65OXYTETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2018 | 60QDK07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2017 | 62CCY99ANTI-HYPERTENSIVE N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/2/2017 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 56ECY65OXYTETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 62BCY02CLOFIBRATE (ANTI-HYPERLIPIDEMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 65JCY20MEDROGESTONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/28/2017 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/12/2017 | 56ECB65OXYTETRACYCLINE (TETRACYCLINES) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 4/19/2017 | 62GAE41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/19/2017 | 56JCE20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2017 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/28/2017 | 56EDY65OXYTETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2017 | 56EDY65OXYTETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/11/2017 | 56ECB20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is PFIZER SA DE CV's FDA import refusal history?
PFIZER SA DE CV (FEI: 3012913761) has 19 FDA import refusal record(s) in our database, spanning from 1/11/2017 to 4/26/2019.
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 SA DE CV's FEI number is 3012913761.
What types of violations has PFIZER SA DE CV received?
PFIZER SA DE CV 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 PFIZER SA DE CV come from?
All FDA import refusal data for PFIZER SA DE CV 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.