Surgical Specialties Mexico S DE RL DE CV
⚠️ Moderate Risk
FEI: 3010692967 • Tijuana, Baja California • MEXICO
FEI Number
3010692967
Location
Tijuana, Baja California
Country
MEXICOAddress
Corredor Tijuana - Rosarito 2000-24702 B, Ejido Francisco Villa, Tijuana, Baja California, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/7/2024 | 79GAKSUTURE, ABSORBABLE | Division of Southeast Imports (DSEI) | |
| 2/19/2021 | 79GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | Division of Northern Border Imports (DNBI) | |
| 2/24/2020 | 79GAWSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | 78STERILITY | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Surgical Specialties Mexico S DE RL DE CV's FDA import refusal history?
Surgical Specialties Mexico S DE RL DE CV (FEI: 3010692967) has 3 FDA import refusal record(s) in our database, spanning from 2/24/2020 to 6/7/2024.
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. Surgical Specialties Mexico S DE RL DE CV's FEI number is 3010692967.
What types of violations has Surgical Specialties Mexico S DE RL DE CV received?
Surgical Specialties Mexico S DE RL DE CV has been cited for 3 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 Surgical Specialties Mexico S DE RL DE CV come from?
All FDA import refusal data for Surgical Specialties Mexico S DE RL DE CV 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.