Carlisle Laboratories Ltd
⚠️ Moderate Risk
FEI: 1000500358 • St Michael • BARBADOS
FEI Number
1000500358
Location
St Michael
Country
BARBADOSAddress
Warrens, , St 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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
NUTRIT LBL
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 fails to bear the required nutrition information.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2019 | 62UBK08CODEINE PHOSPHATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2011 | 61HAZ99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/30/2008 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/19/2008 | 89ITWJOINT, ANKLE, EXTERNAL BRACE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/19/2008 | 56YAO99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/4/2008 | 54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 2/22/2007 | 55QP13SYRUP (PHARMACEUTIC NECESSITY - FLAVOR) | New York District Office (NYK-DO) | |
| 7/26/2006 | 56AYO99PENICILLIN NATURAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 56FDZ13BACITRACIN ZINC (PEPTIDES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 56GAY99ANTIFUNGAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Carlisle Laboratories Ltd's FDA import refusal history?
Carlisle Laboratories Ltd (FEI: 1000500358) has 10 FDA import refusal record(s) in our database, spanning from 3/28/2005 to 4/24/2019.
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 Ltd's FEI number is 1000500358.
What types of violations has Carlisle Laboratories Ltd received?
Carlisle Laboratories Ltd has been cited for 7 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 Ltd come from?
All FDA import refusal data for Carlisle Laboratories 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.