Universal Marine Medical Supply Co.
⚠️ High Risk
FEI: 2434143 • South Plainfield, NJ • UNITED STATES
FEI Number
2434143
Location
South Plainfield, NJ
Country
UNITED STATESAddress
107 Corporate Blvd Ste D, , South Plainfield, 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
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.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/17/2017 | 79LRRKIT, FIRST AID | 179AGR RX | Division of West Coast Imports (DWCI) |
| 9/12/2014 | 63HAA01BISACODYL (CATHARTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 56BBA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 61KAA25HYOSCYAMINE (ANTI-CHOLINERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 61GAO47SULFADIAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 56CAA73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 60CAK51TETRAHYDROZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 62GAA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 60LAO99ANALGESIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 60CAQ48OXYMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 62LAA30MEFLOQUINE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 61KAP04ATROPINE OXIDE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 62VAA43ZIDOVUDINE (ANTI-VIRAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 62FAO34POVIDONE IODINE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/12/2014 | 60CAP04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/29/2012 | 79LRRKIT, FIRST AID | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/21/2008 | 61RCY01DIMERCAPROL (ANTIDOTE) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Universal Marine Medical Supply Co.'s FDA import refusal history?
Universal Marine Medical Supply Co. (FEI: 2434143) has 18 FDA import refusal record(s) in our database, spanning from 8/21/2008 to 7/17/2017.
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. Universal Marine Medical Supply Co.'s FEI number is 2434143.
What types of violations has Universal Marine Medical Supply Co. received?
Universal Marine Medical Supply Co. has been cited for 4 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 Universal Marine Medical Supply Co. come from?
All FDA import refusal data for Universal Marine Medical Supply Co. 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.