Genomma Lab Internacional S.A.B. De C.V.
⚠️ Moderate Risk
FEI: 3008749539 • Mexico, Distrito Federal • MEXICO
FEI Number
3008749539
Location
Mexico, Distrito Federal
Country
MEXICOAddress
Calle Durango No 332 Int 102, Cuauhtemoc, Col. ROMA NORTE, Mexico, Distrito Federal, Mexico
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
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.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2013 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Southwest Import District Office (SWI-DO) | |
| 11/21/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Division of Southwest Imports (DSWI) |
| 11/21/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Southwest Imports (DSWI) | |
| 11/21/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Southwest Imports (DSWI) | |
| 11/21/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Southwest Imports (DSWI) | |
| 11/21/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Southwest Imports (DSWI) | |
| 11/21/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Genomma Lab Internacional S.A.B. De C.V.'s FDA import refusal history?
Genomma Lab Internacional S.A.B. De C.V. (FEI: 3008749539) has 7 FDA import refusal record(s) in our database, spanning from 11/21/2012 to 1/7/2013.
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. Genomma Lab Internacional S.A.B. De C.V.'s FEI number is 3008749539.
What types of violations has Genomma Lab Internacional S.A.B. De C.V. received?
Genomma Lab Internacional S.A.B. De C.V. 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 Genomma Lab Internacional S.A.B. De C.V. come from?
All FDA import refusal data for Genomma Lab Internacional S.A.B. 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.