DSHealthcare Inc. dba Sultan Health Care
⚠️ Moderate Risk
FEI: 1000208911 • Hackensack, NJ • UNITED STATES
FEI Number
1000208911
Location
Hackensack, NJ
Country
UNITED STATESAddress
411 Hackensack Ave Fl 9, , Hackensack, NJ, 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
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.
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).
DE/RX KIT
The article appears to be a combination medical device/prescription drug kit for which the prescription drug component was manufactured in the U.S., is 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 |
|---|---|---|---|
| 4/3/2012 | 63RCQ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 3340DE/RX KIT | Florida District Office (FLA-DO) |
| 4/3/2012 | 76LBHVARNISH, CAVITY | 3340DE/RX KIT | Florida District Office (FLA-DO) |
| 4/3/2012 | 63RCQ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 179AGR RX | Florida District Office (FLA-DO) |
| 4/3/2012 | 63RCQ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 179AGR RX | Florida District Office (FLA-DO) |
| 4/3/2012 | 63RCQ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 179AGR RX | Florida District Office (FLA-DO) |
| 4/3/2012 | 62FDR46CAMPHORATED PARACHLOROPHENOL (ANTI-INFECTIVE, TOPICAL) | 179AGR RX | Florida District Office (FLA-DO) |
| 4/3/2012 | 64ADY05CRESOL (DISINFECTANT) | 179AGR RX | Florida District Office (FLA-DO) |
| 3/11/2011 | 76EHYTRAY, IMPRESSION, PREFORMED | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/11/2011 | 80KCTSTERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is DSHealthcare Inc. dba Sultan Health Care's FDA import refusal history?
DSHealthcare Inc. dba Sultan Health Care (FEI: 1000208911) has 9 FDA import refusal record(s) in our database, spanning from 3/11/2011 to 4/3/2012.
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. DSHealthcare Inc. dba Sultan Health Care's FEI number is 1000208911.
What types of violations has DSHealthcare Inc. dba Sultan Health Care received?
DSHealthcare Inc. dba Sultan Health Care 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 DSHealthcare Inc. dba Sultan Health Care come from?
All FDA import refusal data for DSHealthcare Inc. dba Sultan Health Care 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.