Sanofi US Services, Inc.
⚠️ High Risk
FEI: 2222017 • Morristown, NJ • UNITED STATES
FEI Number
2222017
Location
Morristown, NJ
Country
UNITED STATESAddress
21 South St, , Morristown, NJ, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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.
AGRINSULIN
The article appears to be composed wholly or partly of insulin manufactured in the US and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for a medical emergency
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/22/2023 | 62TDH02LANSOPRAZOLE (ANTI-SECRETORY) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 3/22/2023 | 60QDY30BUPIVACAINE (ANESTHETIC) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 6/30/2022 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 6/28/2021 | 62OCY37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2021 | 87HXBPROBE | Division of Southeast Imports (DSEI) | |
| 5/1/2020 | 61ACA04CHLOROQUINE (ANTI-AMEBIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2020 | 60SBA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 3/25/2020 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northern Border Imports (DNBI) | |
| 11/6/2019 | 62OCA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 11/19/2018 | 62TCA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/7/2016 | 65VDC56ZOLPIDEM TARTRATE (SEDATIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/25/2012 | 62OAA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/25/2012 | 61PAA55METFORMIN HCL (ANTI-DIABETIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/2/2009 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/4/2007 | 61PAY17INSULIN (INJ) (ANTI-DIABETIC) | 2060AGRINSULIN | San Francisco District Office (SAN-DO) |
| 10/2/2007 | 61QDP03DESMOPRESSIN ACETATE (ANTI-DIURETIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 2/6/2007 | 61LAP29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 1/5/2007 | 62ICP99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/1/2005 | 61PDB31GLIMEPIRIDE (ANTI-DIABETIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sanofi US Services, Inc.'s FDA import refusal history?
Sanofi US Services, Inc. (FEI: 2222017) has 28 FDA import refusal record(s) in our database, spanning from 6/1/2005 to 3/22/2023.
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. Sanofi US Services, Inc.'s FEI number is 2222017.
What types of violations has Sanofi US Services, Inc. received?
Sanofi US Services, Inc. has been cited for 8 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 Sanofi US Services, Inc. come from?
All FDA import refusal data for Sanofi US Services, 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.