Reckitt & Colman (Overseas) Ltd.
✅ Low Risk
FEI: 1000353365 • Norwich • UNITED KINGDOM
FEI Number
1000353365
Location
Norwich
Country
UNITED KINGDOMAddress
Carrow, Norwich Nr1 2dd, Morley Street, Norwich, , United Kingdom
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Reckitt & Colman (Overseas) Ltd.'s FDA import refusal history?
Reckitt & Colman (Overseas) Ltd. (FEI: 1000353365) has 1 FDA import refusal record(s) in our database, spanning from 10/5/2009 to 10/5/2009.
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. Reckitt & Colman (Overseas) Ltd.'s FEI number is 1000353365.
What types of violations has Reckitt & Colman (Overseas) Ltd. received?
Reckitt & Colman (Overseas) Ltd. 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 Reckitt & Colman (Overseas) Ltd. come from?
All FDA import refusal data for Reckitt & Colman (Overseas) 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.