Laboratorios Paill
⚠️ High Risk
FEI: 3010327213 • San Salvador, San Salvador • EL SALVADOR
FEI Number
3010327213
Location
San Salvador, San Salvador
Country
EL SALVADORAddress
8a,Av sur y 10ac.Ote. # 470, , San Salvador, San Salvador, El Salvador
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
RX LEGEND
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2026 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2024 | 65QCC24ORPHENADRINE CITRATE (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2024 | 60SCC06BISMUTH (ANTACID) | Division of Southeast Imports (DSEI) | |
| 12/9/2022 | 54AGY04VITAMIN B6 (PYRIDOXINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2019 | 60LBK99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/11/2019 | 62UAA99ANTI-TUSSIVE/COLD N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/11/2019 | 62UBG99ANTI-TUSSIVE/COLD N.E.C. | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 4/10/2014 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/26/2012 | 66VAA99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Laboratorios Paill's FDA import refusal history?
Laboratorios Paill (FEI: 3010327213) has 9 FDA import refusal record(s) in our database, spanning from 12/26/2012 to 1/22/2026.
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. Laboratorios Paill's FEI number is 3010327213.
What types of violations has Laboratorios Paill received?
Laboratorios Paill has been cited for 5 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 Laboratorios Paill come from?
All FDA import refusal data for Laboratorios Paill 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.