Mallinckrodt Hospital Products Inc.
⚠️ Moderate Risk
FEI: 3009140376 • Hazelwood, MO • UNITED STATES
FEI Number
3009140376
Location
Hazelwood, MO
Country
UNITED STATESAddress
675 James S Mcdonnell Blvd, , Hazelwood, MO, 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
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).
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2013 | 60LDS01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/20/2012 | 73JOHTUBE TRACHEOSTOMY AND TUBE CUFF | New Orleans District Office (NOL-DO) | |
| 7/16/2006 | 64PCE09ANAGRELIDE HYDROCHOLORIDE (HEMOSTATIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mallinckrodt Hospital Products Inc.'s FDA import refusal history?
Mallinckrodt Hospital Products Inc. (FEI: 3009140376) has 3 FDA import refusal record(s) in our database, spanning from 7/16/2006 to 1/7/2013.
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. Mallinckrodt Hospital Products Inc.'s FEI number is 3009140376.
What types of violations has Mallinckrodt Hospital Products Inc. received?
Mallinckrodt Hospital Products 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 Mallinckrodt Hospital Products Inc. come from?
All FDA import refusal data for Mallinckrodt Hospital Products 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.