Boots Healthcare Int'L(Export)
⚠️ Moderate Risk
FEI: 3000238955 • Nottingham • UNITED KINGDOM
FEI Number
3000238955
Location
Nottingham
Country
UNITED KINGDOMAddress
P.O.Box 94, , Nottingham, , 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).
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 |
|---|---|---|---|
| 5/25/2006 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 5/25/2006 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 5/25/2006 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 5/25/2006 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 5/25/2006 | 64XAJ06SALICYLIC ACID (KERATOLYTIC) | New York District Office (NYK-DO) | |
| 5/25/2006 | 64XAJ03BENZOYL PEROXIDE (KERATOLYTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/25/2006 | 64XAJ06SALICYLIC ACID (KERATOLYTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Boots Healthcare Int'L(Export)'s FDA import refusal history?
Boots Healthcare Int'L(Export) (FEI: 3000238955) has 7 FDA import refusal record(s) in our database, spanning from 5/25/2006 to 5/25/2006.
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. Boots Healthcare Int'L(Export)'s FEI number is 3000238955.
What types of violations has Boots Healthcare Int'L(Export) received?
Boots Healthcare Int'L(Export) 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 Boots Healthcare Int'L(Export) come from?
All FDA import refusal data for Boots Healthcare Int'L(Export) 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.