BIOTECH SOLUTIONS KAMIL PALMOWSKI
⚠️ Moderate Risk
FEI: 3016086042 • Gdynia, Pomorskie • POLAND
FEI Number
3016086042
Location
Gdynia, Pomorskie
Country
POLANDAddress
Ul. Swietojanska 43/18, , Gdynia, Pomorskie, Poland
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/29/2020 | 79OVNSUTURE KIT | Division of Southeast Imports (DSEI) | |
| 12/29/2020 | 79OVNSUTURE KIT | Division of Southeast Imports (DSEI) | |
| 11/12/2020 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 8/19/2020 | 65QAK02BOTOX | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is BIOTECH SOLUTIONS KAMIL PALMOWSKI's FDA import refusal history?
BIOTECH SOLUTIONS KAMIL PALMOWSKI (FEI: 3016086042) has 4 FDA import refusal record(s) in our database, spanning from 8/19/2020 to 12/29/2020.
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. BIOTECH SOLUTIONS KAMIL PALMOWSKI's FEI number is 3016086042.
What types of violations has BIOTECH SOLUTIONS KAMIL PALMOWSKI received?
BIOTECH SOLUTIONS KAMIL PALMOWSKI has been cited for 5 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 BIOTECH SOLUTIONS KAMIL PALMOWSKI come from?
All FDA import refusal data for BIOTECH SOLUTIONS KAMIL PALMOWSKI 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.