DEPQ Internacional S. de R.L de C.V.
⚠️ Moderate Risk
FEI: 3016788198 • San Luis Potosi, San Luis Potosi • MEXICO
FEI Number
3016788198
Location
San Luis Potosi, San Luis Potosi
Country
MEXICOAddress
Calzada De Guadalupe 2830-A, Col. El Santuario, San Luis Potosi, San Luis Potosi, San Luis Potosi, 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).
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.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/15/2020 | 62HAL99ANTI-MICROBIAL N.E.C. | Division of Southwest Imports (DSWI) | |
| 9/15/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 9/15/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 9/15/2020 | 62HAL99ANTI-MICROBIAL N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/15/2020 | 62HAL99ANTI-MICROBIAL N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/15/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/15/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is DEPQ Internacional S. de R.L de C.V.'s FDA import refusal history?
DEPQ Internacional S. de R.L de C.V. (FEI: 3016788198) has 7 FDA import refusal record(s) in our database, spanning from 9/15/2020 to 9/15/2020.
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. DEPQ Internacional S. de R.L de C.V.'s FEI number is 3016788198.
What types of violations has DEPQ Internacional S. de R.L de C.V. received?
DEPQ Internacional S. de R.L 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 DEPQ Internacional S. de R.L de C.V. come from?
All FDA import refusal data for DEPQ Internacional S. de R.L 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.