L. Perrigo Company
⚠️ High Risk
FEI: 1811666 • Allegan, MI • UNITED STATES
FEI Number
1811666
Location
Allegan, MI
Country
UNITED STATESAddress
515 Eastern Ave, , Allegan, MI, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2022 | 61XBY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/27/2019 | 60LAA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/20/2019 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/23/2012 | 65VAA99SEDATIVE N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/21/2009 | 64XDO12TRETINOIN (KERATOLYTIC) | 179AGR RX | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is L. Perrigo Company's FDA import refusal history?
L. Perrigo Company (FEI: 1811666) has 6 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 11/12/2024.
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. L. Perrigo Company's FEI number is 1811666.
What types of violations has L. Perrigo Company received?
L. Perrigo Company 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 L. Perrigo Company come from?
All FDA import refusal data for L. Perrigo Company 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.