DS Healthcare Group, Inc. dba DS Laboratories
⚠️ Moderate Risk
FEI: 3013687777 • Doral, FL • UNITED STATES
FEI Number
3013687777
Location
Doral, FL
Country
UNITED STATESAddress
2900 Nw 112th Ave # F17, , Doral, FL, 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
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/17/2022 | 62CBY41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southwest Imports (DSWI) | |
| 6/17/2022 | 62CBY41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southwest Imports (DSWI) | |
| 6/17/2022 | 62CBY41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southwest Imports (DSWI) | |
| 6/17/2022 | 62CBY41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southwest Imports (DSWI) | |
| 11/23/2020 | 56YAL99ANTIBIOTIC N.E.C. | Division of Southwest Imports (DSWI) | |
| 11/23/2020 | 62CAL41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southwest Imports (DSWI) | |
| 8/17/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/17/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/17/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/23/2012 | 62CBL41MINOXIDIL (ANTI-HYPERTENSIVE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is DS Healthcare Group, Inc. dba DS Laboratories's FDA import refusal history?
DS Healthcare Group, Inc. dba DS Laboratories (FEI: 3013687777) has 10 FDA import refusal record(s) in our database, spanning from 1/23/2012 to 6/17/2022.
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. DS Healthcare Group, Inc. dba DS Laboratories's FEI number is 3013687777.
What types of violations has DS Healthcare Group, Inc. dba DS Laboratories received?
DS Healthcare Group, Inc. dba DS Laboratories 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 DS Healthcare Group, Inc. dba DS Laboratories come from?
All FDA import refusal data for DS Healthcare Group, Inc. dba DS Laboratories 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.