Eksa Mills S.A. de C.V.
⚠️ Moderate Risk
FEI: 3016927597 • Parque Industrial San Jose Maravillas, Puebla • MEXICO
FEI Number
3016927597
Location
Parque Industrial San Jose Maravillas, Puebla
Country
MEXICOAddress
E. Parque Industrial, Carretera Federal Mexico Veracruz 1056; Puebla, Parque Industrial San Jose Maravillas, Puebla, 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/16/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/16/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 9/16/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Eksa Mills S.A. de C.V.'s FDA import refusal history?
Eksa Mills S.A. de C.V. (FEI: 3016927597) has 3 FDA import refusal record(s) in our database, spanning from 9/16/2020 to 12/16/2020.
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. Eksa Mills S.A. de C.V.'s FEI number is 3016927597.
What types of violations has Eksa Mills S.A. de C.V. received?
Eksa Mills S.A. 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 Eksa Mills S.A. de C.V. come from?
All FDA import refusal data for Eksa Mills 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.