Hospira, Inc.
⚠️ Moderate Risk
FEI: 1925262 • Mcpherson, KS • UNITED STATES
FEI Number
1925262
Location
Mcpherson, KS
Country
UNITED STATESAddress
1776 Centennial Dr, , Mcpherson, KS, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 10/4/2013 | 94RBPINDUSTRIAL ACCELERATOR, NON-MEDICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/20/2011 | 62OCP24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Minneapolis District Office (MIN-DO) |
| 4/20/2011 | 62OCP24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Minneapolis District Office (MIN-DO) |
| 2/27/2007 | 56KCZ85VANCOMYCIN HYDROCHLORIDE | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hospira, Inc.'s FDA import refusal history?
Hospira, Inc. (FEI: 1925262) has 4 FDA import refusal record(s) in our database, spanning from 2/27/2007 to 10/4/2013.
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. Hospira, Inc.'s FEI number is 1925262.
What types of violations has Hospira, Inc. received?
Hospira, 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 Hospira, Inc. come from?
All FDA import refusal data for Hospira, 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.