Pharmacia & Upjohn Company LLC
⚠️ High Risk
FEI: 1810189 • Kalamazoo, MI • UNITED STATES
FEI Number
1810189
Location
Kalamazoo, MI
Country
UNITED STATESAddress
7000 Portage Rd, , Kalamazoo, 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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DR PACKGNG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a drug and its container is so made, formed, or filled as to be misleading
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/25/2025 | 64LCP44METHYLPREDNISOLONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 3/22/2023 | 64LDZ47METHYLPREDNISOLONE SODIUM SUCCINATE (GLUCOCORTICOID) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 6/2/2020 | 64LCY56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2020 | 61GQY61SULFASALAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 9/9/2019 | 56JDY31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 179AGR RX | Division of Southeast Imports (DSEI) |
| 5/8/2015 | 64GDY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/5/2012 | 56DJZ41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | Chicago District Office (CHI-DO) | |
| 7/5/2012 | 56DJZ41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | Chicago District Office (CHI-DO) | |
| 6/25/2012 | 56JCK31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | Chicago District Office (CHI-DO) | |
| 6/21/2012 | 64LAK20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | Los Angeles District Office (LOS-DO) | |
| 10/26/2011 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 12/16/2010 | 57UI31LYMPHOCYTE IMMUNE GLOBULIN, ANTI-THYMOCYTE GLOBULIN | Chicago District Office (CHI-DO) | |
| 12/16/2010 | 56JCM31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | Chicago District Office (CHI-DO) | |
| 8/16/2010 | 56CJK99CEPHALOSPORIN N.E.C. | Chicago District Office (CHI-DO) | |
| 3/24/2009 | 65JIY21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 6/10/2008 | 77JXZPUNCH, GELFOAM | 118NOT LISTED | Detroit District Office (DET-DO) |
| 6/4/2008 | 64LRP45METHYLPREDNISOLONE ACETATE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/17/2006 | 65JCP21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/16/2006 | 64LCP45METHYLPREDNISOLONE ACETATE (GLUCOCORTICOID) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 2/24/2006 | 56JCK31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | New York District Office (NYK-DO) | |
| 2/24/2006 | 56JCK31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | New York District Office (NYK-DO) | |
| 3/15/2005 | 61TCA99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 3/3/2005 | 61PDB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/3/2005 | 61PDB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Pharmacia & Upjohn Company LLC's FDA import refusal history?
Pharmacia & Upjohn Company LLC (FEI: 1810189) has 24 FDA import refusal record(s) in our database, spanning from 3/3/2005 to 7/25/2025.
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. Pharmacia & Upjohn Company LLC's FEI number is 1810189.
What types of violations has Pharmacia & Upjohn Company LLC received?
Pharmacia & Upjohn Company LLC has been cited for 6 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 Pharmacia & Upjohn Company LLC come from?
All FDA import refusal data for Pharmacia & Upjohn Company LLC 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.