CooperVisision Manufacturing Puerto Rico LLC
⚠️ High Risk
FEI: 3002911336 • Juana Diaz, PR • UNITED STATES
FEI
FEI Number
3002911336
📍
Location
Juana Diaz, PR
🇺🇸
Country
UNITED STATES🏢
Address
500 Carr 584, , Juana Diaz, PR, United States
High Risk
FDA Import Risk Assessment
57.4
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
64
Total Refusals
2
Unique Violations
7/30/2019
Latest Refusal
8/24/2012
Earliest Refusal
Score Breakdown
Violation Severity
70.0×40%
Refusal Volume
67.2×30%
Recency
0.0×20%
Frequency
92.3×10%
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
5081×
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 |
|---|---|---|---|
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 7/30/2019 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 8/24/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is CooperVisision Manufacturing Puerto Rico LLC's FDA import refusal history?
CooperVisision Manufacturing Puerto Rico LLC (FEI: 3002911336) has 64 FDA import refusal record(s) in our database, spanning from 8/24/2012 to 7/30/2019.
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. CooperVisision Manufacturing Puerto Rico LLC's FEI number is 3002911336.
What types of violations has CooperVisision Manufacturing Puerto Rico LLC received?
CooperVisision Manufacturing Puerto Rico LLC has been cited for 2 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 CooperVisision Manufacturing Puerto Rico LLC come from?
All FDA import refusal data for CooperVisision Manufacturing Puerto Rico LLC 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.