Laboratorio Pharma International SRL
⚠️ High Risk
FEI: 3012015184 • Tegucigalpa, Francisco Morazan • HONDURAS
FEI Number
3012015184
Location
Tegucigalpa, Francisco Morazan
Country
HONDURASAddress
Edif. Pharma Internacional, Colonia Los Angeles, Calle Principal, Tegucigalpa, Francisco Morazan, Honduras
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/29/2025 | 56GAC99ANTIFUNGAL N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/5/2023 | 62KCC10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/19/2022 | 60LBC05ASPIRIN (ANALGESIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2022 | 62UAL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/10/2022 | 62PBL99ANTI-PYRETIC N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 5/9/2022 | 62LAC99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/9/2022 | 62MBL08MENTHOL (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) | |
| 4/29/2022 | 62DAC99ANTI-HYPOCALCEMIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/29/2022 | 62LAC99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | Division of Southwest Imports (DSWI) | |
| 3/10/2022 | 62PBL99ANTI-PYRETIC N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 3/10/2022 | 61HBA03TRIMETHOPRIM (ANTI-BACTERIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 7/24/2019 | 62MBL08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2019 | 54ACL01VITAMIN A | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorio Pharma International SRL's FDA import refusal history?
Laboratorio Pharma International SRL (FEI: 3012015184) has 13 FDA import refusal record(s) in our database, spanning from 7/11/2019 to 12/29/2025.
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. Laboratorio Pharma International SRL's FEI number is 3012015184.
What types of violations has Laboratorio Pharma International SRL received?
Laboratorio Pharma International SRL has been cited for 8 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 Laboratorio Pharma International SRL come from?
All FDA import refusal data for Laboratorio Pharma International SRL 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.