CAPLIN POINT LABORATORIES LTD
⚠️ Moderate Risk
FEI: 3013139123 • CHENNAI • INDIA
FEI Number
3013139123
Location
CHENNAI
Country
INDIAAddress
NO 4 B EXOTICA BUILDING, , CHENNAI, , India
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/16/2025 | 56DDY20GENTAMICIN (AMINOGLYCOSIDES) | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CAPLIN POINT LABORATORIES LTD's FDA import refusal history?
CAPLIN POINT LABORATORIES LTD (FEI: 3013139123) has 1 FDA import refusal record(s) in our database, spanning from 7/16/2025 to 7/16/2025.
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 POINT LABORATORIES LTD's FEI number is 3013139123.
What types of violations has CAPLIN POINT LABORATORIES LTD received?
CAPLIN POINT LABORATORIES LTD 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 POINT LABORATORIES LTD come from?
All FDA import refusal data for CAPLIN POINT 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.