Pfizer Laboratories
⚠️ Moderate Risk
FEI: 3009679652 • Sandton, Gauteng • SOUTH AFRICA
FEI Number
3009679652
Location
Sandton, Gauteng
Country
SOUTH AFRICAAddress
85 Bute Lane,, 2196, Sandton, Gauteng, South Africa
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/14/2020 | 62EDC02MIDODRINE (ANTI-HYPOTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2016 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/16/2016 | 62IBC85LETROZOLE (ANTI-NEOPLASTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/8/2015 | 61GCY61SULFASALAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pfizer Laboratories's FDA import refusal history?
Pfizer Laboratories (FEI: 3009679652) has 4 FDA import refusal record(s) in our database, spanning from 5/8/2015 to 7/14/2020.
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 Laboratories's FEI number is 3009679652.
What types of violations has Pfizer Laboratories received?
Pfizer Laboratories has been cited for 1 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 Laboratories come from?
All FDA import refusal data for Pfizer Laboratories 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.