Laboratorio MK SRL
⚠️ High Risk
FEI: 3004190832 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3004190832
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Calle 21 No. 4, Sector Villa Aura, , Santo Domingo, , Dominican Republic
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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/12/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2022 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2022 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2022 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/24/2013 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 5/24/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 5/24/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 5/24/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 5/24/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
| 5/24/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Laboratorio MK SRL's FDA import refusal history?
Laboratorio MK SRL (FEI: 3004190832) has 11 FDA import refusal record(s) in our database, spanning from 5/24/2013 to 9/12/2025.
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 MK SRL's FEI number is 3004190832.
What types of violations has Laboratorio MK SRL received?
Laboratorio MK SRL 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 Laboratorio MK SRL come from?
All FDA import refusal data for Laboratorio MK 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.