Farma Quimia S.A. de C.V.
⚠️ Moderate Risk
FEI: 3003887583 • Cuautitlan Izcalli, Mexico • MEXICO
FEI Number
3003887583
Location
Cuautitlan Izcalli, Mexico
Country
MEXICOAddress
Avenida Andre Marie Ampere No 11, Zona Industrial Industrial Cuamatla, Cuautitlan Izcalli, Cuautitlan Izcalli, 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
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.
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).
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.
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 |
|---|---|---|---|
| 5/31/2012 | 60SAS06BISMUTH (ANTACID) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 5/4/2012 | 62WCT11BISMUTH SUBGALLATE ASTRINGENT/ANTI-PERSPIRANT) | New Orleans District Office (NOL-DO) | |
| 8/25/2010 | 60SQZ06BISMUTH (ANTACID) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Farma Quimia S.A. de C.V.'s FDA import refusal history?
Farma Quimia S.A. de C.V. (FEI: 3003887583) has 3 FDA import refusal record(s) in our database, spanning from 8/25/2010 to 5/31/2012.
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. Farma Quimia S.A. de C.V.'s FEI number is 3003887583.
What types of violations has Farma Quimia S.A. de C.V. received?
Farma Quimia S.A. de C.V. has been cited for 5 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 Farma Quimia S.A. de C.V. come from?
All FDA import refusal data for Farma Quimia 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.