Grisi Hnos, S.A. de C.V.
⚠️ High Risk
FEI: 1000424274 • Ciudad De Mexico, Ciudad De Mexico • MEXICO
FEI Number
1000424274
Location
Ciudad De Mexico, Ciudad De Mexico
Country
MEXICOAddress
Avenida Poniente 146 625, Col. Industrial Vallejo, Azcapotzalco, Ciudad De Mexico, Ciudad De Mexico, 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
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).
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).
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.
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.
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).
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/16/2025 | 65QCY31CHLORZOXAZONE (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 54AGY13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2023 | 65QDY31CHLORZOXAZONE (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2021 | 54ACY13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2016 | 62GDA99ANTI-INFLAMMATORY N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/6/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 7/15/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 6/15/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 5/10/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/17/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 3/12/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 2/10/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/10/2010 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/8/2009 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 1/24/2008 | 53FD03HAIR RINSES (COLORING) (HAIR COLORING PREPARATIONS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 1/24/2008 | 53FA06HAIR LIGHTENERS, WITH COLOR (HAIR COLORING PREPARATIONS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 1/4/2008 | 53EC03HAIR STRAIGHTENERS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 4/23/2007 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 3/5/2007 | 62SBY99ANTI-SEBORRHEIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 3/5/2007 | 62SBY99ANTI-SEBORRHEIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 12/13/2006 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 6/4/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 3/4/2004 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 3/4/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 3/4/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 3/4/2004 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 10/22/2002 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/7/2002 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/7/2002 | 53JL01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 11/27/2001 | 68CBY10SMALL ANIMAL ANTISEPTIC | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Grisi Hnos, S.A. de C.V.'s FDA import refusal history?
Grisi Hnos, S.A. de C.V. (FEI: 1000424274) has 30 FDA import refusal record(s) in our database, spanning from 11/27/2001 to 6/16/2025.
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. Grisi Hnos, S.A. de C.V.'s FEI number is 1000424274.
What types of violations has Grisi Hnos, S.A. de C.V. received?
Grisi Hnos, S.A. de C.V. has been cited for 9 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 Grisi Hnos, S.A. de C.V. come from?
All FDA import refusal data for Grisi Hnos, 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.