La Ada de Acuna, S. de R.L. de C.V.
⚠️ High Risk
FEI: 3003807323 • Ciudad De Acuna, Coahuila • MEXICO
FEI Number
3003807323
Location
Ciudad De Acuna, Coahuila
Country
MEXICOAddress
Carreterra Presa La Amistad Km 4.5, Parque Industrial Amistad, , Ciudad De Acuna, Coahuila, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/27/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/21/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/6/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/6/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 9/6/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 6/8/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 6/8/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 6/7/2023 | 80FXXMASK, SURGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 6/6/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 6/6/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 5/31/2023 | 80FXXMASK, SURGICAL | Division of Southeast Imports (DSEI) | |
| 5/31/2023 | 80FXXMASK, SURGICAL | 2380NO PMA/PDP | Division of Southeast Imports (DSEI) |
| 5/23/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/11/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/11/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/11/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/11/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/11/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/10/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/10/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/6/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/6/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 4/3/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 3/31/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 3/31/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/31/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/31/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/31/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/31/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/31/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/24/2023 | 80FXXMASK, SURGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 3/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 3/7/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 3/3/2023 | 80FXXMASK, SURGICAL | Division of Northeast Imports (DNEI) | |
| 3/3/2023 | 80FXXMASK, SURGICAL | Division of Northeast Imports (DNEI) | |
| 2/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 2/17/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 2/7/2023 | 80FXXMASK, SURGICAL | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 1/30/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 1/30/2023 | 80FXXMASK, SURGICAL | 508NO 510(K) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is La Ada de Acuna, S. de R.L. de C.V.'s FDA import refusal history?
La Ada de Acuna, S. de R.L. de C.V. (FEI: 3003807323) has 59 FDA import refusal record(s) in our database, spanning from 1/30/2023 to 9/27/2023.
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. La Ada de Acuna, S. de R.L. de C.V.'s FEI number is 3003807323.
What types of violations has La Ada de Acuna, S. de R.L. de C.V. received?
La Ada de Acuna, S. de R.L. de C.V. has been cited for 4 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 La Ada de Acuna, S. de R.L. de C.V. come from?
All FDA import refusal data for La Ada de Acuna, 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.