Iron Lab, S.A. de C.V.
⚠️ Moderate Risk
FEI: 3016605971 • Lerma, Edo de Mexico • MEXICO
FEI Number
3016605971
Location
Lerma, Edo de Mexico
Country
MEXICOAddress
Zona Industrial Lerma, Emiliano Zapata No. 159 Int. 10-B, Lerma, Edo de Mexico, 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
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).
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 |
|---|---|---|---|
| 5/20/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 4/15/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 10/1/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 6/8/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Iron Lab, S.A. de C.V.'s FDA import refusal history?
Iron Lab, S.A. de C.V. (FEI: 3016605971) has 4 FDA import refusal record(s) in our database, spanning from 6/8/2020 to 5/20/2021.
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. Iron Lab, S.A. de C.V.'s FEI number is 3016605971.
What types of violations has Iron Lab, S.A. de C.V. received?
Iron Lab, 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 Iron Lab, S.A. de C.V. come from?
All FDA import refusal data for Iron Lab, 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.