CAPLIN LABS
⚠️ Moderate Risk
FEI: 3012657177 • Guatemala • GUATEMALA
FEI Number
3012657177
Location
Guatemala
Country
GUATEMALAAddress
Zona 4 Local 37, , Guatemala, , Guatemala
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/7/2016 | 56ECA20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/7/2016 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/7/2016 | 61WCO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/7/2016 | 62GCE90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/7/2016 | 61WCA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is CAPLIN LABS's FDA import refusal history?
CAPLIN LABS (FEI: 3012657177) has 5 FDA import refusal record(s) in our database, spanning from 9/7/2016 to 9/7/2016.
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. CAPLIN LABS's FEI number is 3012657177.
What types of violations has CAPLIN LABS received?
CAPLIN LABS has been cited for 1 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 CAPLIN LABS come from?
All FDA import refusal data for CAPLIN LABS 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.