Stryker Sustainability Solutions, Inc.
⚠️ Moderate Risk
FEI: 1000132435 • Lakeland, FL • UNITED STATES
FEI Number
1000132435
Location
Lakeland, FL
Country
UNITED STATESAddress
5300 Region Ct, , Lakeland, FL, United States
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article 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.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/11/2016 | 87HRXARTHROSCOPE AND ACCESSORIES | 341REGISTERED | Seattle District Office (SEA-DO) |
| 5/11/2016 | 78NLMLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED | 341REGISTERED | Seattle District Office (SEA-DO) |
| 5/11/2016 | 79NLQSCALPEL, ULTRASONIC, REPROCESSED | 341REGISTERED | Seattle District Office (SEA-DO) |
| 5/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Seattle District Office (SEA-DO) |
| 5/11/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Seattle District Office (SEA-DO) |
| 5/4/2016 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 341REGISTERED | Seattle District Office (SEA-DO) |
| 7/1/2013 | 79GCJLAPAROSCOPE, GENERAL & PLASTIC SURGERY | Seattle District Office (SEA-DO) | |
| 4/10/2012 | 87HRXARTHROSCOPE AND ACCESSORIES | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/10/2012 | 74DRCTROCAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 4/10/2012 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/19/2011 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Stryker Sustainability Solutions, Inc.'s FDA import refusal history?
Stryker Sustainability Solutions, Inc. (FEI: 1000132435) has 11 FDA import refusal record(s) in our database, spanning from 12/19/2011 to 5/11/2016.
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. Stryker Sustainability Solutions, Inc.'s FEI number is 1000132435.
What types of violations has Stryker Sustainability Solutions, Inc. received?
Stryker Sustainability Solutions, Inc. 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 Stryker Sustainability Solutions, Inc. come from?
All FDA import refusal data for Stryker Sustainability Solutions, Inc. 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.