Molekula Ltd
⚠️ Moderate Risk
FEI: 3004938330 • Poole, Dorset • UNITED KINGDOM
FEI Number
3004938330
Location
Poole, Dorset
Country
UNITED KINGDOMAddress
Technology Road, , Poole, Dorset, United Kingdom
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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/29/2007 | 62LCS99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/24/2007 | 61WIZ52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 9/28/2006 | 60DIR99ADRENOCORTICAL STEROID N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/9/2006 | 56YAR99ANTIBIOTIC N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/22/2005 | 60HAC99ALDOSTERONE ANTAGONIST, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Molekula Ltd's FDA import refusal history?
Molekula Ltd (FEI: 3004938330) has 5 FDA import refusal record(s) in our database, spanning from 9/22/2005 to 10/29/2007.
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. Molekula Ltd's FEI number is 3004938330.
What types of violations has Molekula Ltd received?
Molekula Ltd 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 Molekula Ltd come from?
All FDA import refusal data for Molekula Ltd 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.