Unipharm S.A.
⚠️ Moderate Risk
FEI: 3008270707 • Villa Nueva, Guatemala • GUATEMALA
FEI Number
3008270707
Location
Villa Nueva, Guatemala
Country
GUATEMALAAddress
Km 18, , Villa Nueva, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2024 | 60LCY69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2022 | 62GDY90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/2/2016 | 56CCY70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Unipharm S.A.'s FDA import refusal history?
Unipharm S.A. (FEI: 3008270707) has 3 FDA import refusal record(s) in our database, spanning from 3/2/2016 to 11/4/2024.
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. Unipharm S.A.'s FEI number is 3008270707.
What types of violations has Unipharm S.A. received?
Unipharm S.A. has been cited for 2 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 Unipharm S.A. come from?
All FDA import refusal data for Unipharm S.A. 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.