Healtylab Mexicana Sa De Cv
⚠️ High Risk
FEI: 3012145648 • Monterrey, Nuevo Leon • MEXICO
FEI Number
3012145648
Location
Monterrey, Nuevo Leon
Country
MEXICOAddress
Calle Licenciado Jose Benitez No. 2526, Col. OBISPADO, Monterrey, Nuevo Leon, Mexico
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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
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.
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 |
|---|---|---|---|
| 9/8/2017 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 482NUTRIT LBL | Division of Southwest Imports (DSWI) |
| 5/26/2017 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 3/20/2017 | 53LC07NIGHT (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 3/20/2017 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southwest Imports (DSWI) | |
| 3/14/2017 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southwest Imports (DSWI) | |
| 3/14/2017 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southwest Imports (DSWI) | |
| 3/8/2017 | 54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 238UNSAFE ADD | Division of Southwest Imports (DSWI) |
| 2/17/2017 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 2/17/2017 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 7/29/2016 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 7/5/2016 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 7/5/2016 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Healtylab Mexicana Sa De Cv's FDA import refusal history?
Healtylab Mexicana Sa De Cv (FEI: 3012145648) has 12 FDA import refusal record(s) in our database, spanning from 7/5/2016 to 9/8/2017.
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. Healtylab Mexicana Sa De Cv's FEI number is 3012145648.
What types of violations has Healtylab Mexicana Sa De Cv received?
Healtylab Mexicana Sa De Cv 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 Healtylab Mexicana Sa De Cv come from?
All FDA import refusal data for Healtylab Mexicana Sa De Cv 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.