Healthylab Mexicana, S.A. de C.V.

⚠️ Moderate Risk

FEI: 3012133601 • Ramos Arizpe, Coahuila • MEXICO

FEI

FEI Number

3012133601

📍

Location

Ramos Arizpe, Coahuila

🇲🇽

Country

MEXICO

🏢

Address

Blvd. Parque Industrial # 4057-B, Parque Industrial Ramos Arizpe, Ramos Arizpe, Coahuila, Mexico

Moderate Risk

FDA Import Risk Assessment

43.4

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

7/18/2019

Latest Refusal

1/9/2018

Earliest Refusal

Score Breakdown

Violation Severity

60.5×40%

Refusal Volume

40.0×30%

Recency

0.0×20%

Frequency

72.3×10%

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

Violation Summary

4825×

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.

114×

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).

2604×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

2742×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

2382×

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.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

751×

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
7/18/2019	54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
2/27/2019	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	482NUTRIT LBL	Division of Southwest Imports (DSWI)
2/27/2019	54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	11UNSAFE COL	Division of Southwest Imports (DSWI)
7/31/2018	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	482NUTRIT LBL	Division of Southwest Imports (DSWI)
6/20/2018	54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	482NUTRIT LBL	Division of Southwest Imports (DSWI)
6/20/2018	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	260FALSE	Division of Southwest Imports (DSWI)
6/18/2018	54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	473LABELING 482NUTRIT LBL	Division of Southwest Imports (DSWI)
5/29/2018	54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	238UNSAFE ADD 260FALSE 75UNAPPROVED	Division of Southwest Imports (DSWI)
4/13/2018	54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	11UNSAFE COL 274COLOR LBLG 482NUTRIT LBL	Division of Southwest Imports (DSWI)
3/12/2018	54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.	11UNSAFE COL 238UNSAFE ADD 260FALSE	Division of Southwest Imports (DSWI)
1/9/2018	41YGT99DIETARY CONVENTIONAL FOODS, N.E.C.	260FALSE	Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Healthylab Mexicana, S.A. de C.V.'s FDA import refusal history?

Healthylab Mexicana, S.A. de C.V. (FEI: 3012133601) has 11 FDA import refusal record(s) in our database, spanning from 1/9/2018 to 7/18/2019.

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. Healthylab Mexicana, S.A. de C.V.'s FEI number is 3012133601.

What types of violations has Healthylab Mexicana, S.A. de C.V. received?

Healthylab Mexicana, S.A. de C.V. has been cited for 7 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 Healthylab Mexicana, S.A. de C.V. come from?

All FDA import refusal data for Healthylab Mexicana, S.A. de C.V. 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.