Dester Corporation
⚠️ Moderate Risk
FEI: 3009731017 • College Park, GA • UNITED STATES
FEI Number
3009731017
Location
College Park, GA
Country
UNITED STATESAddress
2077 Convention Center Concourse Ste 450, , College Park, GA, 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.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2023 | 80NSBPATIENT PERSONAL HYGIENE KIT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/1/2020 | 80NSBPATIENT PERSONAL HYGIENE KIT | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 6/23/2020 | 80NSBPATIENT PERSONAL HYGIENE KIT | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 5/16/2020 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 2/5/2020 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 2/5/2020 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 10/8/2019 | 80NSBPATIENT PERSONAL HYGIENE KIT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/8/2019 | 80NSBPATIENT PERSONAL HYGIENE KIT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/23/2019 | 80NSBPATIENT PERSONAL HYGIENE KIT | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/23/2019 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 8/23/2019 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 8/19/2019 | 80NSBPATIENT PERSONAL HYGIENE KIT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/23/2019 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 9/27/2018 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 9/27/2018 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 9/26/2018 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 8/21/2018 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 8/21/2018 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 3/20/2018 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) | |
| 3/9/2018 | 80NSBPATIENT PERSONAL HYGIENE KIT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Dester Corporation's FDA import refusal history?
Dester Corporation (FEI: 3009731017) has 21 FDA import refusal record(s) in our database, spanning from 3/9/2018 to 5/22/2023.
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. Dester Corporation's FEI number is 3009731017.
What types of violations has Dester Corporation received?
Dester Corporation 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 Dester Corporation come from?
All FDA import refusal data for Dester Corporation 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.