Carlisle Laboratories Limited
⚠️ Moderate Risk
FEI: 3000838792 • Saint Michael • BARBADOS
FEI Number
3000838792
Location
Saint Michael
Country
BARBADOSAddress
P O Box 682c Warrens Ind Park, , Saint Michael, , Barbados
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).
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/13/2023 | 61ECY08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/6/2022 | 61CCL99ANTI-ANEMIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/12/2019 | 62UDL20DEXTROMETHORPHAN POLISTIREX (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2012 | 54FCL24SENNA (HERBAL & BOTANICALS, NOT TEAS) | 488HEALTH C | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Carlisle Laboratories Limited's FDA import refusal history?
Carlisle Laboratories Limited (FEI: 3000838792) has 4 FDA import refusal record(s) in our database, spanning from 1/7/2012 to 10/13/2023.
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. Carlisle Laboratories Limited's FEI number is 3000838792.
What types of violations has Carlisle Laboratories Limited received?
Carlisle Laboratories Limited 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 Carlisle Laboratories Limited come from?
All FDA import refusal data for Carlisle Laboratories Limited 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.