Pfizer Pharmaceutical India Pvt Limited
⚠️ Moderate Risk
FEI: 3009662616 • Navi Mumbai, Maharashtra • INDIA
FEI Number
3009662616
Location
Navi Mumbai, Maharashtra
Country
INDIAAddress
Plot No 16, Ttc Midc; Ku Bazarpost; Thane Belapur Road, Navi Mumbai, Maharashtra, India
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 |
|---|---|---|---|
| 6/29/2020 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/10/2012 | 68YDA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/10/2012 | 68YDA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 10/10/2012 | 68YDA10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Pfizer Pharmaceutical India Pvt Limited's FDA import refusal history?
Pfizer Pharmaceutical India Pvt Limited (FEI: 3009662616) has 4 FDA import refusal record(s) in our database, spanning from 10/10/2012 to 6/29/2020.
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 Pharmaceutical India Pvt Limited's FEI number is 3009662616.
What types of violations has Pfizer Pharmaceutical India Pvt Limited received?
Pfizer Pharmaceutical India Pvt Limited 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 Pharmaceutical India Pvt Limited come from?
All FDA import refusal data for Pfizer Pharmaceutical India Pvt Limited 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.