Company
United StatesStructure Medical LLC, Naples, FL – FDA Inspections
Inspection records and compliance data for Structure Medical LLC in Naples, Florida. 4 FDA inspections on record, 1 Form 483, last inspected January 19, 2024.
Company Profile
This profile covers Structure Medical LLC based in Naples, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 1, 2014. Last inspected January 19, 2024.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Quality audits - Lack of or inadequate procedures3 inspections
- Lack of or inadequate complaint procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 19, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1228547 |
| March 3, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1006383 |
| November 21, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 905640 |
| August 1, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 889407 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Structure Medical LLC
FEI Number
3009322142
Address
9935 Business Cir, Naples, Florida 34112, United States
Country
United States
ID: a8ee6514-beaf-4f38-883a-2046e246e2e7