Plasticos Protesicos, S.A.
⚠️ Moderate Risk
FEI: 1000444830 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
1000444830
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle San Borja No. 1361, Otro Vertz Narvarte, Benito Juarez, Ciudad De Mexico, Ciudad 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2001 | 86HPZIMPLANT, EYE SPHERE | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Plasticos Protesicos, S.A.'s FDA import refusal history?
Plasticos Protesicos, S.A. (FEI: 1000444830) has 1 FDA import refusal record(s) in our database, spanning from 11/20/2001 to 11/20/2001.
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. Plasticos Protesicos, S.A.'s FEI number is 1000444830.
What types of violations has Plasticos Protesicos, S.A. received?
Plasticos Protesicos, S.A. has been cited for 1 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 Plasticos Protesicos, S.A. come from?
All FDA import refusal data for Plasticos Protesicos, S.A. 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.