PAUL AND CO (LONDON) LTD
⚠️ Moderate Risk
FEI: 3009340804 • London • UNITED KINGDOM
FEI Number
3009340804
Location
London
Country
UNITED KINGDOMAddress
Unit D1 New Southgate Industrial Estate, , London, , 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2014 | 76EFWTOOTHBRUSH, MANUAL | Florida District Office (FLA-DO) | |
| 1/28/2014 | 53YF99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Florida District Office (FLA-DO) | |
| 1/28/2014 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | Florida District Office (FLA-DO) | |
| 1/28/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is PAUL AND CO (LONDON) LTD's FDA import refusal history?
PAUL AND CO (LONDON) LTD (FEI: 3009340804) has 4 FDA import refusal record(s) in our database, spanning from 1/28/2014 to 1/28/2014.
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. PAUL AND CO (LONDON) LTD's FEI number is 3009340804.
What types of violations has PAUL AND CO (LONDON) LTD received?
PAUL AND CO (LONDON) LTD 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 PAUL AND CO (LONDON) LTD come from?
All FDA import refusal data for PAUL AND CO (LONDON) 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.