PAIL
⚠️ Moderate Risk
FEI: 3021428557 • Tegucigalpa, Francisco Morazan • HONDURAS
FEI Number
3021428557
Location
Tegucigalpa, Francisco Morazan
Country
HONDURASAddress
Contiguo A Bod. De Dhl, , Tegucigalpa, Francisco Morazan, Honduras
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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2022 | 62GBC49NAPROXEN (ANTI-INFLAMMATORY) | 306INSANITARY | Division of Southwest Imports (DSWI) |
| 4/29/2022 | 60LBC05ASPIRIN (ANALGESIC) | Division of Southwest Imports (DSWI) | |
| 4/29/2022 | 62GBL49NAPROXEN (ANTI-INFLAMMATORY) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is PAIL's FDA import refusal history?
PAIL (FEI: 3021428557) has 3 FDA import refusal record(s) in our database, spanning from 4/29/2022 to 7/18/2022.
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. PAIL's FEI number is 3021428557.
What types of violations has PAIL received?
PAIL has been cited for 4 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 PAIL come from?
All FDA import refusal data for PAIL 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.