Incredible Products, SA de CV
⚠️ High Risk
FEI: 3009788529 • Guadalajara, Jalisco • MEXICO
FEI Number
3009788529
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Calle Castellanos Y Tapia 921, Col. Santa Maria, Guadalajara, Guadalajara, Jalisco, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
REDUCED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug that a substance has been mixed or packed with so as to reduce its strength.
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/25/2025 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 3/14/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 3/14/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 3/14/2024 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 2/28/2022 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/28/2022 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/1/2021 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 9/1/2021 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 9/1/2021 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 9/1/2021 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 6/22/2021 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 6/22/2021 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southwest Imports (DSWI) | |
| 9/9/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 1/16/2014 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Incredible Products, SA de CV's FDA import refusal history?
Incredible Products, SA de CV (FEI: 3009788529) has 14 FDA import refusal record(s) in our database, spanning from 1/16/2014 to 6/25/2025.
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. Incredible Products, SA de CV's FEI number is 3009788529.
What types of violations has Incredible Products, SA de CV received?
Incredible Products, SA de CV 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 Incredible Products, SA de CV come from?
All FDA import refusal data for Incredible Products, 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.