CONSUMER HEALTH CARE GROUP, Pfizer Inc.
⚠️ Moderate Risk
FEI: 3002445574 • New York, NY • UNITED STATES
FEI Number
3002445574
Location
New York, NY
Country
UNITED STATESAddress
unknown, , New York, NY, United States
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 8/21/2009 | 60SDL06BISMUTH (ANTACID) | 179AGR RX | Southwest Import District Office (SWI-DO) |
| 10/16/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 8/2/2007 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is CONSUMER HEALTH CARE GROUP, Pfizer Inc.'s FDA import refusal history?
CONSUMER HEALTH CARE GROUP, Pfizer Inc. (FEI: 3002445574) has 3 FDA import refusal record(s) in our database, spanning from 8/2/2007 to 8/21/2009.
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. CONSUMER HEALTH CARE GROUP, Pfizer Inc.'s FEI number is 3002445574.
What types of violations has CONSUMER HEALTH CARE GROUP, Pfizer Inc. received?
CONSUMER HEALTH CARE GROUP, Pfizer Inc. 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 CONSUMER HEALTH CARE GROUP, Pfizer Inc. come from?
All FDA import refusal data for CONSUMER HEALTH CARE GROUP, 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.