LABORATORIES LAMFER
⚠️ Moderate Risk
FEI: 3012707436 • SACATEPEQUEZ • GUATEMALA
FEI Number
3012707436
Location
SACATEPEQUEZ
Country
GUATEMALAAddress
KM 16.5 CARRETERA A SAN, , SACATEPEQUEZ, , 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 |
|---|---|---|---|
| 1/19/2021 | 56ECA20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2020 | 66MDY83HYDROXYZINE HCL (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/19/2020 | 56YCC99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2020 | 62HCY99ANTI-MICROBIAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/14/2016 | 64LDL19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIES LAMFER's FDA import refusal history?
LABORATORIES LAMFER (FEI: 3012707436) has 5 FDA import refusal record(s) in our database, spanning from 10/14/2016 to 1/19/2021.
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. LABORATORIES LAMFER's FEI number is 3012707436.
What types of violations has LABORATORIES LAMFER received?
LABORATORIES LAMFER 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 LABORATORIES LAMFER come from?
All FDA import refusal data for LABORATORIES LAMFER 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.