Laboratorios Labocont Industrial SRL
⚠️ Moderate Risk
FEI: 3010166941 • Santo Domingo Este, Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3010166941
Location
Santo Domingo Este, Santo Domingo
Country
DOMINICAN REPUBLICAddress
Km., Autopista Las Americas 19, Santo Domingo Este, Santo Domingo, Dominican Republic
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).
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/9/2020 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/6/2020 | 60LBJ99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/6/2017 | 62MDJ08MENTHOL (ANTI-PRURITIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 1/22/2016 | 60LBJ99ANALGESIC, N.E.C. | 473LABELING | San Juan District Office (SJN-DO) |
| 12/1/2014 | 60LBL99ANALGESIC, N.E.C. | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Laboratorios Labocont Industrial SRL's FDA import refusal history?
Laboratorios Labocont Industrial SRL (FEI: 3010166941) has 5 FDA import refusal record(s) in our database, spanning from 12/1/2014 to 4/9/2020.
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 Labocont Industrial SRL's FEI number is 3010166941.
What types of violations has Laboratorios Labocont Industrial SRL received?
Laboratorios Labocont Industrial SRL 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 Laboratorios Labocont Industrial SRL come from?
All FDA import refusal data for Laboratorios Labocont Industrial 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.