HK Kolmar USA LLC
⚠️ Moderate Risk
FEI: 1000221288 • Scott Township, PA • UNITED STATES
FEI Number
1000221288
Location
Scott Township, PA
Country
UNITED STATESAddress
102 Life Science Dr, , Scott Township, PA, 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(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/8/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/8/2017 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/1/2017 | 66PBU99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/1/2017 | 66PBU99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/1/2017 | 66PBU99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 1/9/2013 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is HK Kolmar USA LLC's FDA import refusal history?
HK Kolmar USA LLC (FEI: 1000221288) has 6 FDA import refusal record(s) in our database, spanning from 1/9/2013 to 11/8/2017.
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. HK Kolmar USA LLC's FEI number is 1000221288.
What types of violations has HK Kolmar USA LLC received?
HK Kolmar USA LLC has been cited for 2 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 HK Kolmar USA LLC come from?
All FDA import refusal data for HK Kolmar USA LLC 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.