CAPLIN POINT LABORATORIES OF GUA
⚠️ High Risk
FEI: 3026486415 • Guatemala City • GUATEMALA
FEI Number
3026486415
Location
Guatemala City
Country
GUATEMALAAddress
5th Avenue Zone 5 Calle, , Guatemala City, , Guatemala
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 12/5/2025 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/5/2025 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2023 | 62KCY11NITAZOXANIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/3/2023 | 62GDY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CAPLIN POINT LABORATORIES OF GUA's FDA import refusal history?
CAPLIN POINT LABORATORIES OF GUA (FEI: 3026486415) has 5 FDA import refusal record(s) in our database, spanning from 5/3/2023 to 12/5/2025.
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 OF GUA's FEI number is 3026486415.
What types of violations has CAPLIN POINT LABORATORIES OF GUA received?
CAPLIN POINT LABORATORIES OF GUA 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 OF GUA come from?
All FDA import refusal data for CAPLIN POINT LABORATORIES OF GUA 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.